Ethicon Endo Surgery, LLC: PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1

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: 1,080 units Lot/code info: Product Code: Z127H-50; GMDN: 16584; UDI-DI: 10705031060227; Lot number: 104BQC;

UPC codes

10705031060227

Source

Official record: FDA (Device enforcement) ↗

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