Reported Oct 28, 2020 · Terminated
VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic…
Ethicon, Inc.
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: Ethicon, Inc. · Us Highway 22 West · Somerville, NJ · 08876
Is this the product you have?
- VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2)
- SINGLE-ARMED CS140-6 - Product UsageIntended for ophthalmic soft tissue approximation/ligation
- Product CodeV960G
- Lot codes and dates
- Lot/Serial No.:
- PJ5352 Expiry Date07/31/2024
- UDI (GTIN)10705031051324
- Amount recalled
- 1,032 eaches (OUS only)
Why it was recalled
Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. The correct VICRYL suture is size 10-0, 4 inches (10 cm) in length, has monofilament construction, and a single needle. The incorrect VICRYL suture is size 6-0, 18 inches (45 cm) in length, has braided construction, and two needles
This product could cause temporary or reversible health problems — stop using it.
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