# FDA recall Z-1181-2023

> **Covidien, LP** · Class II · device recall initiated 2022-12-02.

## Product

Ti-Cron Coated Braided Polyester Suture  Product Description  88862775-31 TICRON* 4-0 BLU 75CM CV327DA  88862880-41 TICRON* 3-0 WHI 75CM Y31DA  88863012-61 TICRON* 0 BLU 90CM C16 X36  88863015-61 TICRON* 0 BLU 120CM V20X36  88863017-51 TICRON* 2-0 BLU 120CM SKX36  88863026-71 TICRON* 1 BLU 75CM HOS12X36  88863035-51 TICRON 2-0 BLU 105CM CV305DA  88863047-41 TICRON* 3-0 BLU 45CM C13X36  88863048-51 TICRON* 2-0 BLU 75CM C13X36  88863050-61 TICRON* 0 BLU 75CM C14 X36  88863054-51 TICRON* 2-0 BLU 75CM C17X36  88863056-89 TICRON* 5 BLU 45CM GS18X12  88863059-53 TICRON* 2-0 BLU 45CM P24X12  88863070-51 TICRON* 2-0 BLU 75CM C15X36  88863088-51 TICRON* 2-0 BLU 75CM Y5X36  88863090-51 TICRON 2-0 BLU 75CM GS21X36  88863092-71 TICRON* 1 BLU 75CM KV37X36  88863109-43 TICRON* 3-0 BLU 45CM P22X12  88863111-79 TICRON* 5 BLU 75CM HGS21X36  88863119-61 TICRON* 0 BLU 75CM KV34X36  88863154-09 TICRON* 4 BLU 75CM GS11X36  88863159-31 TICRON* 4-0 BLU 90CM KV5DA  88863160-41 TICRON* 3-0 BLU 90CM Y31DA  8886

## 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

## Distribution

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

## Key facts

- **Recall number:** Z-1181-2023
- **Recalling firm:** Covidien, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-02
- **Report date:** 2023-03-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Haven, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1181-2023

## Citation

> AI Analytics. FDA recall Z-1181-2023. Retrieved 2026-09-22 from https://api.ai-analytics.org/recall/Z-1181-2023. Source: US FDA. Licensed CC0.

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