FDA-Device2020-10-28Class II
VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approximation/ligation. Product Code: V960G
Ethicon, Inc.
Hazard
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
Sold states
International distribution including the countries of Australia, Canada, Japan, and New Zealand
Affected count
1,032 eaches (OUS only)
Manufactured in
Us Highway 22 West, N/A, Somerville, NJ, United States
Products
VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approximation/ligation. Product Code: V960G
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0116-2021Don't want to check this manually?
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