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Integra Lifesciences Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457 - safety alert

Official notice

18 Jan 2023

MediumFDA

An official FDA notice concerns Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-01-18. Lots: was, 6396457. Recall numbers: Z-0909-2023. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

168

Recall number

Z-0909-2023

Official notice

2023-01-18

The hazard

Health risk requiring medical assessment

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

was, 6396457

Other

UDI-DI 10381780514961

Event Ids

91280

Recall Numbers

Z-0909-2023

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Affected products

Product 1

Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457

Units affected

168

Risk / hazard

Health risk requiring medical assessment

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States

Affected area 1

US · United States

Affected area 2

AU · Australia

Affected area 3

CL · Chile

Affected area 4

FR · France

Affected area 5

GB · United Kingdom

Affected area 6

IE · Ireland

Affected area 7

NZ · New Zealand

Affected area 8

RO · Romania

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Integra Lifesciences. Contact: Integra LifeSciences Corp..

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-0909-2023

Event id

91280

Units affected

168

Status

active

Classification

Class II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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