MONOCRYL Surgical Sutures Recalled for Packaging Sterility Defect
Ethicon recalls 306,000 MONOCRYL surgical sutures worldwide due to holes in primary packaging from a manufacturing defect that compromises sterility and could result in infection.
What this means for you
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 FDA Class II medical device recall presents significant infection risk due to packaging defects compromising sterility. No illnesses or injuries have been reported; the hazard is high-consequence but theoretical, meeting the rubric criterion for score 3.
Plain-English summary
Ethicon, Inc. is recalling approximately 306,000 units of MONOCRYL (poliglecaprone 25) Suture, a medical device used for general soft tissue approximation and ligation in surgical procedures.
The recall was initiated due to an issue with a specific packaging machine that resulted in holes in the primary packaging. This defect compromised product sterility, creating a potential risk of infection if the product is used.
The affected sutures were distributed worldwide, including throughout the United States, Puerto Rico, and to Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, Israel, Japan, Kuwait, Mexico, New Zealand, Panama, Saudi Arabia, Singapore, Uruguay, and South Africa.
Healthcare providers and consumers who have these sutures should discontinue use and contact Ethicon, Inc. for further instructions regarding the affected lot numbers.
The recalled product
- Product
- MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H
- Manufacturer
- Ethicon, Inc.
- Hazard
- infection
- sterility-compromise
- packaging-defect
Distribution
Distributed nationwide across the United States.
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