Reported Apr 19, 2023 · Ongoing
Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915),…
Covidien, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien, LP · 60 Middletown Ave · North Haven, CT · 06473-3908
Is this the product you have?
Chromic Gut Absorbable SuturesSURGIGUT* 0 CHR GS-25 90CM X36 (CG-904)SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915)CHROMIC GUT 4-0 75CM V20 (GG-121)CHROMIC GUT 3-0 75CM V20 X36 (GG-122)CHROMIC GUT 2-0 75CM V20 X36 (GG-123)CHROMIC GUT 2-0 75CM V26 (GG-127)CHROMIC GUT 4-0 45CM P12 X36 (SG-5637)CHROMIC GUT 5-0 45CM P-13 X12 (SG-5687G)CHROMIC GUT 5-0 75CM CV23 (UG-202)CHROMIC GUT 4-0 75CM CV23 X36 (UG-203)
- Lot codes and dates
- GTIN
20884521054001208845210540562088452105488920884521054896208845210548962088452105490220884521054902108845210549052088452105494020884521055688208845210557702088452105613510884521056145208845210561422088452105614220884521056142
- Lot
D2H1593ZYD2H1022ZYD2F1106ZYD2H1607ZYD2H1609ZYD2H0819ZYD2H2053ZYD2H2053ZYD2H2055ZYD2H1435FZYD2H0829FZYD2H0830FZYD2H0381ZYD2H1523ZYD2H1584ZYD2H1584ZYD2H1587ZYD2H1589ZY
- GTIN
- Amount recalled
- 36204 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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