# FDA recall Z-1174-2023

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

## Product

Monosof Monofilament Nylon sutures:  Product Description    CN-724 MONOSOF* 1 BLK 100CM GS25 X36									  CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36									  CN-791-12 MONOSOF* 2-0 BLK 100CM GCC90									  CN-793 MONOSOF* 1 BLK 100CM GCC90 X36									  									  CN-793-12 MONOSOF* 1 BLK 100CM GCC90X12									  CN-830-L MONOSOF* 1 BLK 150CM LP GS25									  N-2781K MONOSOF* 5-0 BLK 45CM SS24 DAX12									  SN-1647 MONOSOF* 7-0 BLK 45CM P16 X36									  SN-1647G MONOSOF* 7-0 BLK 45CM P16 X12									  SN-247 MONOSOF* 3-0 BLK 90CM C23 X36				  				  SN-3686 MONOSOF* 7-0 BLK 45CM P10 X12									  									  SN-3695 MONOSOF* 5-0 BLK 45CM P10 X12									  									  									  									  SN-3697 MONOSOF* 6-0 BLK 45CM P10 X12									  									  SN-3965 MONOSOF* 5-0 BLK 45CM PC11 X12									  SN-5660G MONOSOF* 6-0 BLK 45CM P24 X12									  SN-5665G MONOSOF* 6-0 BLK 45CM P12 X12									  SN-5690G MONOSOF* 5-0 CLR 45CM P13 X12									  SN-5691 MONOSOF* 4-0 CLR 45CM P13 X36									 

## 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-1174-2023
- **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-1174-2023

## Citation

> AI Analytics. FDA recall Z-1174-2023. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-1174-2023. Source: US FDA. Licensed CC0.

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