Device product
PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
Z-1513-2025
Product summary
- Event
- Event 96461
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 792 units
- Official record key
device-enforcement:Z-1513-2025
Official wording
Reason: Identified curing issues with the silicone during the needles manufacturing process.
Code information: Product Code: PDP127H-14; GMDN: 47362; UDI-DI: 10705031047907; Lot number: 104M7E;
Distribution pattern: 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.
Derived failure modes
-
Unknown
Identified curing issues with the silicone during the needles manufacturing process.