Ethicon Endo Surgery, LLC: PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM

Hazard

Identified curing issues with the silicone during the needles manufacturing process.

Details from the source

Reason for recall: Identified curing issues with the silicone during the needles manufacturing process. Distribution: Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, Uruguay. Quantity: 37,080 units Lot/code info: Product Code: (1) 8706H-15, (2) 8711H-16; GMDN: 13909; UDI-DI: (1) 10705031019430, (2) 10705031019560; Lot number: 104E88, 104E89, 1047TZ, 104BQ0, 104DA2, 104JAR, 104JPJ, 104SES, 104KHD, 104SER;

UPC codes

10705031019430, 10705031019560

Source

Official record: FDA (Device enforcement) ↗

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