FDA Device Recall Z-0720-2020: Abbott Medical

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0720-2020.

Recall Res Number

Z-0720-2020

Recalling Firm / Manufacturer

Abbott Medical

FEI Number

3005334138

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2019-11-11

Date Posted

N/A

Date Terminated

2021-04-01

Product Code

GXI

Event Number

84295

Product Quantity

470 devices

Product Description CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.

Reason for Recall A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm active tip length cannulas.

Action Details The firm initiated the recall by hand delivered letter on 11/11/2019. The letter explained the issue and requested the return of the recalled product.

Distribution Pattern Worldwide distribution - US Nationwide and country of Bermuda.

Code Information / Serial Numbers UDI (01) 05415067028693(17)220131(10) 6865795 lot 6865795

Related Establishments / Registrations

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Viant AS&O Holdings, LLC Registration: 1221485 View Registration
GEOTEC, INC. Registration: 1222773 View Registration
SPECTRA MEDICAL DEVICES, LLC Registration: 1224960 View Registration
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center Registration: 1225687 View Registration
Bausch & Lomb Incorporated Registration: 1313525 View Registration
EPIMED INTERNATIONAL, INC. Registration: 1316297 View Registration
Sterigenics U.S., LLC Registration: 1319639 View Registration
Isomedix Operations, Inc. Registration: 1450662 View Registration
ISOMEDIX OPERATIONS INC Registration: 1526711 View Registration
Abbott Medical Registration: 1627487 View Registration
Epimed International, Inc. Registration: 1643059 View Registration
ISOMEDIX OPERATIONS INC Registration: 1643817 View Registration
MedXL Registration: 1644312 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1720929 View Registration
MERIT MEDICAL SYSTEMS, INC. Registration: 1721504 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
CEA Medical Manufacturing, Inc. Registration: 1721983 View Registration
Bausch & Lomb Incorporated Registration: 1920664 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
Sterigenics U.S., LLC Registration: 2029275 View Registration
Isomedix Operations, Inc. Registration: 2030624 View Registration
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Boston Scientific Corporation Registration: 2124215 View Registration
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Abbott Medical Registration: 2135147 View Registration
St. Jude Medical, Atrial Fibrillation Division, Inc. Registration: 2182269 View Registration
PMT CORP. Registration: 2182979 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
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Bausch+Lomb Netherlands B.V. Amsterdam Logistics Centre Registration: 3003365815 View Registration
QUALITY TECH SERVICES, LLC Registration: 3003477135 View Registration
MINTA MEDICAL LIMITED Registration: 3004617090 View Registration
NISSHA MEDICAL TECHNOLOGIES SAS Registration: 3004762958 View Registration
OSCOR CARIBE LLC Registration: 3004785273 View Registration
ARMOR PLAST LTD Registration: 3005160949 View Registration
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Merit Medical Nederland BV Registration: 3006950086 View Registration
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safemed medical devices s.r.o. Registration: 3007221462 View Registration
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STRYKER MANUFACTURING KALAMAZOO Registration: 3007997036 View Registration
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SYMMETRY MEDICAL POLYVAC SAS Registration: 3008534770 View Registration
RIVERSIDE MEDICAL PACKAGING COMPANY LTD Registration: 3008559295 View Registration
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BIOMERICS Registration: 3008998256 View Registration
LCCS PRODUCTS LIMITED Registration: 3009241989 View Registration
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ARVATO Netherlands B.V. Registration: 3013302242 View Registration
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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-0720-2020

Recall Parameters & Description

Related Establishments / Registrations

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