Ethicon Recalls VICRYL Plus Sutures Due to Labeling Mismatches
Ethicon, Inc. is recalling VICRYL Plus Sutures because the product may not match the sales unit carton and foil label.
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 the hazard involves labeling mismatches which are considered moderate risks under the rubric for minor labeling errors or low-risk contamination.
Plain-English summary
Ethicon, Inc. is recalling VICRYL Plus Sutures under FDA recall number Z-1135-2019. The recall involves 550,681 units of VICRYL Plus Sutures in various sizes and colors, including 18-inch and 27-inch lengths. The products are intended for general soft tissue approximation and ligation, including ophthalmic procedures, but are not for use in cardiovascular and neurological tissues.
The reason for the recall is that the product may not match the sales unit carton and foil label. This discrepancy could lead to the use of the wrong suture type or size during a procedure. The affected products were distributed worldwide, including in the United States, Australia, Belgium, Canada, China, Israel, Japan, Puerto Rico, and Singapore.
Healthcare providers and facilities should check their inventory for the specific lot numbers and product codes listed in the recall notice. If any of the affected products are found, they should be removed from use and returned to Ethicon, Inc. according to the company's instructions. Patients who have had surgery using these sutures should contact their healthcare provider if they have concerns.
The recalled product
- Product
- VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 UND VICRYL PLUS SUTURE 18"(45CM) 0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 VIO) VICRYL PLUS SUTURE 18"(45CM) 1 VIO VICRYL PLUS SUTURE 18"(45CM) 4-0 VIO VICRYL PLUS SUTURE 27"(70CM) 3-0…
- Manufacturer
- Ethicon, Inc.
- Hazard
- Affected units
- 550,681
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Ethicon, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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