Covidien llc

Entity profile compiled from public source records

Public Record Profile Registrations: 22 510(k) filings: 13 Recalls: 39

Known Identifiers & Locations

FEI Numbers 1219930, 1282497, 1717344, 2024500, 2647580, 2936999, 3001227743, 3002807391, 3002807626, 3002807850, 3002808696, 3003382061, 3003495548, 3003521774, 3004904811, 3004962788, 3006451981, 3008361498, 3010326740, 3013242701, 3023294726, 3026612481
Owner Operator Numbers 1282497
Locations Covered - Galway, IE; - Santo Domingo, DO; ATHLONE Westmeath, IE; BOULDER, CO, US; CARLSBAD, CA, US; Ciudad Juarez Chihuahua, MX; JERUSALEM, IL; Lafayette, CO, US; MANSFIELD, MA, US; MIRANDOLA Modena, IT; Min Hang District Shanghai, CN; North Haven, CT, US; PONCE, PR, US; Plainfield, IN, US; Plymouth, MN, US; Reggiolo (RE) Reggio Emilia, IT; Rolo Reggio Emilia, IT; Santa Clara, CA, US; Shanghai, CN; TIJUANA, B.C. Mexico, MX; TREVOUX Auvergne-Rhone-Alpes, FR

Registered Establishments (22)

Registration # Establishment Name Location Establishment Type(s) Action
1219930 Covidien North Haven, CT, US Manufacture Medical Device View Details
1282497 Covidien LLC MANSFIELD, MA, US Manufacture Medical Device View Details
1717344 Covidien BOULDER, CO, US Manufacture Medical Device View Details
2024500 COVIDIEN CARLSBAD, CA, US Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility View Details
2647580 Covidien PONCE, PR, US Manufacture Medical Device View Details
2936999 Covidien Lafayette, CO, US Develop Specifications But Do Not Manufacture At This Facility View Details
3004904811 Covidien llc Santa Clara, CA, US Develop Specifications But Do Not Manufacture At This Facility View Details
3004962788 Covidien llc Plymouth, MN, US Develop Specifications But Do Not Manufacture At This Facility View Details
3006451981 Covidien Medical Products (Shanghai) Manufacturing LLC Shanghai, CN Manufacture Medical Device View Details
3008361498 Covidien Plainfield, IN, US Manufacture Medical Device View Details
3010326740 Medtronic (Shanghai) Medical Technology Co., Ltd. Min Hang District Shanghai, CN Develop Specifications But Do Not Manufacture At This Facility View Details
3013242701 MEDTRONIC ITALIA Rolo Reggio Emilia, IT Export Device to the United States But Perform No Other Operation on Device View Details
3023294726 Mallinckrodt Dar S.r.l. Reggiolo (RE) Reggio Emilia, IT Sterilize Medical Device for Another Party (Contract Sterilizer) View Details
3026612481 Covidien Lafayette, CO, US Develop Specifications But Do Not Manufacture At This Facility View Details
8020889 Mallinckrodt Medical ATHLONE Westmeath, IE Manufacture Medical Device View Details
8020893 Covidien - Galway, IE Manufacture Medical Device View Details
8044004 ORIDION MEDICAL 1987 LTD. JERUSALEM, IL Develop Specifications But Do Not Manufacture At This Facility View Details
9610849 Covidien TIJUANA, B.C. Mexico, MX Manufacture Medical Device View Details
9612501 Covidien - Santo Domingo, DO Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
9615742 SOFRADIM PRODUCTION TREVOUX Auvergne-Rhone-Alpes, FR Manufacture Medical Device View Details
9680661 Mallinckrodt Dar S.r.l. MIRANDOLA Modena, IT Manufacture Medical Device View Details
9681384 Covidien Ciudad Juarez Chihuahua, MX Manufacture Medical Device View Details

510(k) Premarket Notifications (13)

Submission # Device Name Decision Date Decision Description Action
K120863 WHOLEY GUIDE WIRE SYSTEM 2012-04-19 Substantially Equivalent View Details
K121139 ACCUMESH DEPLOYMENT SYSTEM 2012-05-02 Substantially Equivalent View Details
K141542 NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS ) 2014-10-02 Substantially Equivalent View Details
K142654 Fortrex 0.035 OTW PTA Balloon Catheter 2014-10-28 Substantially Equivalent View Details
K150251 Barrx Anorectal RFA Wand 2015-07-28 Substantially Equivalent View Details
K151376 superDimension Navigation System 2015-11-05 Substantially Equivalent View Details
K160360 Barrx FLEX RFA Energy Generator 2016-04-05 Substantially Equivalent View Details
K163654 VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar 2017-03-08 Substantially Equivalent View Details
K173244 superDimension Navigation System V7.2 2018-02-08 Substantially Equivalent View Details
K193356 BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider 2020-03-02 Substantially Equivalent View Details
K211561 INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) 2021-12-05 Substantially Equivalent View Details
K233341 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) 2024-05-20 Substantially Equivalent View Details
K243785 Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced 2025-09-25 Substantially Equivalent View Details

FDA Recall History (39)

Recall # Product Description Initiation Date Status Action
Z-0013-2019 Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing. Reason: Potential for product sterility breach due to a compromised or pinched seal defect 2018-08-01 Terminated View Details
Z-0014-2019 Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds. Reason: Potential for product sterility breach due to a compromised or pinched seal defect 2018-08-01 Terminated View Details
Z-0015-2019 Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds. Reason: Potential for product sterility breach due to a compromised or pinched seal defect 2018-08-01 Terminated View Details
Z-0016-2019 Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds. Reason: Potential for product sterility breach due to a compromised or pinched seal defect 2018-08-01 Terminated View Details
Z-0017-2019 Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds. Reason: Potential for product sterility breach due to a compromised or pinched seal defect 2018-08-01 Terminated View Details
Z-0018-2019 Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds. Reason: Potential for product sterility breach due to a compromised or pinched seal defect 2018-08-01 Terminated View Details
Z-0043-2015 Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R Reason: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators 2014-09-18 Terminated View Details
Z-0044-2015 Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected Part Number: 22660PC Reason: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs 2014-09-18 Terminated View Details
Z-0045-2015 Covidien Kendall Adult Multi-Function Defibrillation Electrodes Part Number: 20660 Reason: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs 2014-09-18 Terminated View Details
Z-0046-2015 Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number: 40000006 Reason: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs 2014-09-18 Terminated View Details
Z-0047-2015 MediChoice Multifunction Electrode Part Number: MC171 OH Reason: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs 2014-09-18 Terminated View Details
Z-0048-2015 Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A Reason: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs 2014-09-18 Terminated View Details
Z-0070-2019 EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis. Reason: The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma. There have been no reports of serious injury related to this issue. 2018-08-17 Terminated View Details
Z-0210-2022 Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1 Reason: The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling system failure. Use of an affected device in conjunction with a primary cooling system failure could lead to the applicator tip overheating and associated heat damage which could result in an allergic/toxic reaction, unintended tissue ablation, tissue burn, and/or a delay of treatment while an alternate device is located. 2021-09-29 Terminated View Details
Z-0329-2016 Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion. Reason: Incorrectly packaged with a 90 degree bend at the distal tip 2015-10-14 Terminated View Details
Z-0330-2016 Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145017P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion. Reason: Incorrectly packaged with a 90 degree bend at the distal tip 2015-10-14 Terminated View Details
Z-0331-2016 Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion. Reason: Incorrectly packaged with a 90 degree bend at the distal tip 2015-10-14 Terminated View Details
Z-0332-2016 Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145046C The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion. Reason: Incorrectly packaged with a 90 degree bend at the distal tip 2015-10-14 Terminated View Details
Z-0332-2022 Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA Reason: Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth (Ground) circuit 2021-11-12 Open, Classified View Details
Z-0333-2016 Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145061P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion. Reason: Incorrectly packaged with a 90 degree bend at the distal tip 2015-10-14 Terminated View Details
Z-0338-2022 Puritan Bennett 980 Series Ventilator, 980A1ENNISB Reason: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. 2021-11-04 Terminated View Details
Z-0339-2022 Puritan Bennett 980 Series Ventilator, 980A3ENNISB Reason: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. 2021-11-04 Terminated View Details
Z-0340-2022 Puritan Bennett 980 Series Ventilator, 980S1ENDICU Reason: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. 2021-11-04 Terminated View Details
Z-0341-2022 Puritan Bennett 980 Series Ventilator, 980S3ENDICU Reason: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. 2021-11-04 Terminated View Details
Z-0342-2022 Puritan Bennett 980 Series Ventilator, 980U1ENASAA Reason: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. 2021-11-04 Terminated View Details
Z-0343-2022 Puritan Bennett 980 Series Ventilator, 980U1ESDIUC Reason: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. 2021-11-04 Terminated View Details
Z-0344-2022 Puritan Bennett 980 Series Ventilator, 980U3ESDIUU Reason: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. 2021-11-04 Terminated View Details
Z-0345-2022 Puritan Bennett 980 Series Ventilator,980X1ENAIQC Reason: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. 2021-11-04 Terminated View Details
Z-0346-2022 Puritan Bennett 980 Series Ventilator, 980X1ENDIPC Reason: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. 2021-11-04 Terminated View Details
Z-0347-2022 Puritan Bennett 980 Series Ventilator, 980X1ENDIUU Reason: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. 2021-11-04 Terminated View Details
Z-0348-2022 Puritan Bennett 980 Series Ventilator, 980X1ENNISB Reason: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. 2021-11-04 Terminated View Details
Z-0349-2022 Puritan Bennett 980 Series Ventilator, 980X1JADIJJ Reason: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. 2021-11-04 Terminated View Details
Z-0350-2022 Puritan Bennett 980 Series Ventilator, 980X1PLDIPC Reason: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. 2021-11-04 Terminated View Details
Z-0351-2022 Puritan Bennett 980 Series Ventilator, 980X2ESDIEC Reason: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. 2021-11-04 Terminated View Details
Z-0352-2022 Puritan Bennett 980 Series Ventilator, 980X3ENDIUU Reason: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. 2021-11-04 Terminated View Details
Z-0353-2022 Puritan Bennett 980 Series Ventilator, 980X3JADIJJ Reason: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. 2021-11-04 Terminated View Details
Z-0364-2017 Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles Reason: Added Instructions for Use: After application, inspect the Light Glove for barrier integrity 2016-09-29 Terminated View Details
Z-0365-2017 Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles Reason: Added Instructions for Use: After application, inspect the Light Glove for barrier integrity 2016-09-29 Terminated View Details
Z-0366-2017 Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006 MAJOR BASIN PACK 400383007 MAJOR BASIN PACK 618275004 BASIN PACK Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles Reason: Added Instructions for Use: After application, inspect the Light Glove for barrier integrity 2016-09-29 Terminated View Details

Profile Disclaimer

AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.

Account Required Full available specs will require a free AvaSpecs account.