Ethicon, Inc.: PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalm

Hazard

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

Details from the source

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 . 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. Quantity: 45828 units Lot/code info: GTIN: 10705031047976 10705031048027 10705031048119 PRODUCT CODE PRODUCT LOTS PDP304H TLMJLZ PDP316H UAMKDC PDP341H UBMCZA

UPC codes

10705031047976, 10705031048027, 10705031048119

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.