FDA Device Recall Z-0002-2017: Merit Medical Systems, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0002-2017.

Recall Res Number

Z-0002-2017

Recalling Firm / Manufacturer

Merit Medical Systems, Inc.

FEI Number

1721504

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2016-08-25

Date Posted

N/A

Date Terminated

2016-12-01

Product Code

MAV

Event Number

75127

Product Quantity

1,297 total units

Product Description Merit Inflation Syringe Kit. Catalog Number KOS-02857

Reason for Recall Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.

Action Details Merit Medical Inc. notified all affected customers on August 25, 2016, via verbal and written notification to return the affected units. The returned units will be re-labeled. For further questions, please call (801) 316-3690.

Distribution Pattern One consignee located in CA. No Canadian, other foreign or VA/govt/military consignees.

Code Information / Serial Numbers Lot Numbers: H959038, H970334, H984351.

Related Establishments / Registrations

Boston Scientific Corporation Registration: 1000121056 View Registration
C.R. BARD, INC. Registration: 1018233 View Registration
Sterigenics U.S., LLC Registration: 1018470 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1043214 View Registration
ATRION MEDICAL PRODUCTS, INC. Registration: 1043729 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration
DeRoyal Industries, Inc. Registration: 1054241 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1055236 View Registration
DeRoyal Industries, Inc. Registration: 1060680 View Registration
MEDTRONIC VASCULAR Registration: 1220452 View Registration
Sterigenics U.S., LLC Registration: 1319639 View Registration
ICU Medical, Inc. Registration: 1526863 View Registration
ARGON MEDICAL DEVICES INC. Registration: 1625425 View Registration
MedXL Registration: 1644312 View Registration
MERIT MEDICAL SYSTEMS, INC. Registration: 1721504 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
Sterigenics U.S., LLC Registration: 1721686 View Registration
Terumo BCT STERILIZATION SERVICES, Inc. Registration: 1724474 View Registration
Cook Incorporated Registration: 1820334 View Registration
Cook Incorporated Registration: 1825146 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
Sterigenics US LLC Registration: 2011171 View Registration
BARD PERIPHERAL VASCULAR, INC. Registration: 2020394 View Registration
ABBOTT VASCULAR Registration: 2024168 View Registration
Boston Scientific Corporation Registration: 2124215 View Registration
ABBOTT VASCULAR Registration: 2939561 View Registration
Synergy Health Ireland Ltd Registration: 3002807314 View Registration
Teleflex Medical de Tecate, S. de R.L de C.V. Registration: 3003898360 View Registration
Abbott Vascular Netherlands Registration: 3004091615 View Registration
Sterigenics US LLC Registration: 3004111573 View Registration
BOSTON SCIENTIFIC CORPORATION Registration: 3004859241 View Registration
BOSTON SCIENTIFIC CORPORATION Registration: 3005099803 View Registration
COOK MEDICAL LLC Registration: 3005580113 View Registration
Sterigenics Belgium Petit Rechain S.A. Registration: 3005941719 View Registration
C.R. BARD, INC. Registration: 3006082230 View Registration
Perouse Medical Registration: 3006942524 View Registration
Merit Medical Nederland BV Registration: 3006950086 View Registration
SHENZHEN ANTMED CO. LTD Registration: 3007048453 View Registration
ALLWELL MEDICAL CORPORATION Registration: 3007138831 View Registration
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD. Registration: 3007361214 View Registration
FOREFRONT (XIAMEN) MEDICAL DEVICES CO., LTD. Registration: 3007695715 View Registration
ADVANCED LIFESCIENCES PVT. LTD. Registration: 3007830707 View Registration
Teleflex LLC (NADC) Registration: 3010041511 View Registration
BIOTRONIX HEALTHCARE INDUSTRIES INC. Registration: 3010131137 View Registration
BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD. Registration: 3010141307 View Registration
FOREFRONT MEDICAL TECHNOLOGY (JIANGSU) CO.,LTD Registration: 3010149039 View Registration
AvailMed S.A.De C.V. Registration: 3010291427 View Registration
LILMO Ltd Registration: 3010872792 View Registration
Gyrus ACMI, Inc. Registration: 3011050570 View Registration
Teleflex Medical LLC Registration: 3011137372 View Registration
ICU Medical, Inc. Registration: 3012307300 View Registration
Merit Medical Canada Ltd. Registration: 3012536737 View Registration
BURAK GLOBAL IC VE DIS TIC LTD STI Registration: 3014461810 View Registration
WORLDWIDE SUPPLIES LIMITED Registration: 3014579161 View Registration
Merit Medical Asia Company Limited Registration: 3015225571 View Registration
Merit Medical UK Limited Registration: 3015309643 View Registration
TIANJIN DEMAX MEDICAL TECHNOLOGY CO., LTD. Registration: 3022815697 View Registration
Ates Distribution Registration: 3024893679 View Registration
TZ MEDICAL, INC. Registration: 3027815 View Registration
PLATINUM FOCUS GROUP LTD. Registration: 3030446844 View Registration
Merit Medical Australia Pty Ltd. Registration: 3033589330 View Registration
AESCULAP AG Registration: 9610612 View Registration
Boston Scientific Limited Registration: 9616684 View Registration
Boston Scientific Limited Registration: 9681260 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0002-2017

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer