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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: 792 units Lot/code info: Product Code: PDP127H-14; GMDN: 47362; UDI-DI: 10705031047907; Lot number: 104M7E;

UPC codes

10705031047907

Source

Official record: FDA (Device enforcement) ↗

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