Ethicon MONOCRYL Plus Sutures Recalled for Packaging Defect
Ethicon recalled 287,892 MONOCRYL Plus Antibacterial Sutures worldwide due to a packaging machine defect that created holes in primary packaging, potentially compromising sterility and risking infection.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with a packaging defect that compromises sterility and could result in infection. No illnesses or injuries have been reported to date, qualifying this as a high-severity risk-of-harm product where injury has not yet been reported.
Plain-English summary
Ethicon, Inc. is recalling MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture, an absorbable surgical suture intended for general soft tissue approximation and ligation. The recall was issued due to a defect on a specific packaging machine that resulted in holes in the primary packaging, which could compromise product sterility.
The recall affects 287,892 units identified by multiple product codes and lot numbers. The affected product was distributed worldwide, including throughout the United States, Puerto Rico, and to countries in South America, Europe, Asia, the Middle East, Africa, and Oceania.
While no infections have been reported to date, the packaging defect could allow microorganisms to compromise sterility, potentially resulting in infection at the surgical site. Healthcare facilities and consumers should cease use of the affected product and contact Ethicon, Inc. immediately if they have questions or concerns about the recalled sutures.
The recalled product
- Product
- MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CODE: MCP266H13 MCP3200H16 MCP3212H16 MCP3213H16 MCP340H13 MCP345H13 MCP416H14 MCP417H14…
- Manufacturer
- Ethicon, Inc.
- Affected units
- 287,892
Distribution
Part of a larger recall action
This product is one of 6 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.
See all 6 products in this recall →Related recalls
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Similar recalls
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