Ethicon, Inc. recalls MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an abs

Recalled June 26, 2024 · FDA recall Z-2148-2024 · Ethicon

Hazard

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . · FDA Class II

Units

306000 units

Sold at

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.

Description

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

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(s)

Ethicon, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →