CLASS II ONGOING Device recall · Reported 8 Mar 2023 · FDA Enforcement Report

Us1638 Custom Suture Pack Us1756 Custom Suture Pack recalled by Covidien

Covidien is recalling Us1638 Custom Suture Pack Us1756 Custom Suture Pack, distributed nationwide in the US. The recall was initiated on 2 Dec 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN: N/A Model Number Lot # US1638: A1K0289Y, A1K0291Y, US1638 A1K0283Y ; US1756: A2E0454Y

Quantity recalled9606

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1182-2023
FDA event ID: 91324
Recalling firm: Covidien, North Haven, CT
Classification: Class II
Status: Ongoing
Recall initiated: 2 Dec 2022
FDA classified: 25 Feb 2023
Reported: 8 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

2 Dec 2022	Recall initiated by company
25 Feb 2023	Classified by FDA	+85 days
8 Mar 2023	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK

Where it was distributed

US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia Cameroon Canada Canary Islands Chile China Colombia Croatia Czech Republic Denmark Egypt Finland France Georgia Germany Ghana Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy JAPAN Jordan Kazakhstan Kenya Korea, Republic Of Kosovo Kuwait Latvia Lebanon Lithuania Macao Malaysia Malta Mauritius Mexico Moldova, Republic Of Morocco Myanmar Namibia Netherlands New Zealand North Macedonia Norway Pakistan Panama Paraguay Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam Zimbabwe

Nationwide Georgia

Questions about this recall

Is Us1638 Custom Suture Pack Us1756 Custom Suture Pack recalled?

Yes. Covidien recalled Us1638 Custom Suture Pack Us1756 Custom Suture Pack on 2 Dec 2022. The recall is Class II and its status is Ongoing. Recall number Z-1182-2023.

Why was it recalled?

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Which lots are affected?

GTIN: N/A Model Number Lot # US1638: A1K0289Y, A1K0291Y, US1638 A1K0283Y ; US1756: A2E0454Y

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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