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
Reported: June 26, 2024 Initiated: May 10, 2024 #Z-2148-2024
Product Description
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
Reason for Recall
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Details
- Recalling Firm
- Ethicon, Inc.
- Units Affected
- 306000 units
- Distribution
- Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.
- Location
- Raritan, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ethicon, Inc.. Units affected: 306000 units.
Why was this product recalled? ▼
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 26, 2024. Severity: Moderate. Recall number: Z-2148-2024.
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