Ethicon, Inc. recalls PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardi

Recalled June 26, 2024 · FDA recall Z-2146-2024 · 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

56952 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

PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: D6261 Z117H Z149H Z259H Z305H Z320H

Manufacturer(s)

Ethicon, Inc.

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