Ethicon Recalls VICRYL Sutures Due to Packaging Mismatch
Ethicon is recalling VICRYL sutures because the foil package may not match the label and carton. The incorrect suture differs in size, length, and construction.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling/packaging mismatch that could lead to the use of an incorrect suture size and type, posing a moderate risk of procedural error.
Plain-English summary
Ethicon, Inc. is recalling VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 sutures. The recall is due to a discrepancy where the product in the foil package 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. The affected lot number is PJ5352 with an expiry date of 07/31/2024.
The recall involves 1,032 units distributed internationally, including Australia, Canada, Japan, and New Zealand. The product is intended for ophthalmic soft tissue approximation and ligation. Users should check their inventory for the specific lot number and contact Ethicon for instructions.
The recalled product
- Product
- 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
- Manufacturer
- Ethicon, Inc.
- Affected units
- 1,032
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot/Serial No.: PJ5352 Expiry Date: 07/31/2024 UDI (GTIN): 10705031051324
Distribution
Distribution scope not specified by the agency.
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