FDA Device Recall Z-0664-2020: Abbott Medical

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0664-2020.

Recall Res Number

Z-0664-2020

Recalling Firm / Manufacturer

Abbott Medical

FEI Number

3005334138

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2019-10-14

Date Posted

N/A

Date Terminated

2021-07-19

Product Code

GXD

Event Number

84272

Product Quantity

8940 devices

Product Description Radiofrequency Grounding Pad, REF RF-DGP-L

Reason for Recall Affected lots were manufactured with the protective release liner in an incorrect orientation. When attempting to remove this disposable release liner, a clear film may be left on the grounding pad which may interfere with patient skin contact and lead to uneven heating.

Action Details The firm initiated the recall by letter hand delivered by an Abbott field representative. The letter requested that consignee cease use of the affected lot and return the product with the aid of a field representative.

Distribution Pattern nationwide

Code Information / Serial Numbers UDI: 05415067028914 Batch Numbers: 810319004, 810319005, and 810319021

Related Establishments / Registrations

SFM Medical Devices GmbH Registration: 1000632857 View Registration
MEDTRONIC SOFAMOR DANEK USA, INC. Registration: 1030489 View Registration
SPECTRA MEDICAL DEVICES, LLC Registration: 1224960 View Registration
EPIMED INTERNATIONAL, INC. Registration: 1316297 View Registration
Sterigenics U.S., LLC Registration: 1319639 View Registration
Abbott Medical Registration: 1627487 View Registration
Epimed International, Inc. Registration: 1643059 View Registration
MedXL Registration: 1644312 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
CEA Medical Manufacturing, Inc. Registration: 1721983 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
Boston Scientific Corporation Registration: 2124215 View Registration
BENCHMARK ELECTRONICS, INC. Registration: 2133786 View Registration
Abbott Medical Registration: 2135147 View Registration
St. Jude Medical, Atrial Fibrillation Division, Inc. Registration: 2182269 View Registration
NORTECH SYSTEMS, INC. Registration: 2183613 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
St. Jude Medical, Atrial Fibrillation Division, Inc. Registration: 2184149 View Registration
APICAL INSTRUMENTS Registration: 2954783 View Registration
LINEMASTER SWITCH CORP. Registration: 3001592626 View Registration
MEDTRONIC SOFAMOR DANEK USA, INC. Registration: 3003120897 View Registration
QUALITY TECH SERVICES, LLC Registration: 3003477135 View Registration
ARMOR PLAST LTD Registration: 3005160949 View Registration
St. Jude Medical, Cardiology Division, Inc. Registration: 3005334138 View Registration
Sterigenics Belgium Petit Rechain S.A. Registration: 3005941719 View Registration
Boston Scientific Neuromodulation Corporation Registration: 3006630150 View Registration
AMPHENOL ALDEN PRODUCTS COMPANY Registration: 3007029079 View Registration
safemed medical devices s.r.o. Registration: 3007221462 View Registration
Boston Scientific Corporation Registration: 3007695959 View Registration
STRYKER MANUFACTURING KALAMAZOO Registration: 3007997036 View Registration
STRYKER EMEA Supply Chain Services Registration: 3008837339 View Registration
Cathay Manufacturing Corp. Registration: 3009555600 View Registration
QXMEDICAL, LLC Registration: 3009766315 View Registration
RBC Development LLC dba RBC Medical Innovations dba Vantage MedTech Registration: 3010126772 View Registration
Stellartech Research Corp. Registration: 3010653929 View Registration
CUSTOM TUBE MANUFACTURING LLC Registration: 3010966701 View Registration
Avanos Medical, Inc. Registration: 3011270181 View Registration
Medline Industries, LP - Mexicali (MXC) Registration: 3015173212 View Registration
Stryker Instruments Registration: 3015967359 View Registration
NEUROONE MEDICAL TECHNOLOGIES CORP. Registration: 3016438686 View Registration
Schneider ASR B.V. Registration: 3016678045 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
BAYLIS MEDICAL TECHNOLOGIES INC. Registration: 3020968442 View Registration
AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration
RBC Development LLC dba RBC Medical Innovations dba Vantage MedTech Registration: 3043527620 View Registration
STRYKER LEIBINGER GMBH & CO. KG Registration: 8010177 View Registration
DIROS TECHNOLOGY, INC. Registration: 8043398 View Registration
PAJUNK GMBH MEDIZINTECHNOLOGIE Registration: 9611612 View Registration
Boston Scientific Limited Registration: 9616693 View Registration
Venusa de Mexico S. de R.L de C.V Registration: 9680001 View Registration
Avent S. de R.L. de C.V. Registration: 9680425 View Registration

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Medical Device Recall: Z-0664-2020

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer