Device product
LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
Z-0141-2026
Product summary
- Event
- Event 97603
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 0 units
- Official record key
device-enforcement:Z-0141-2026
Official wording
Reason: The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Code information: 1. UPN: 72404405 (12CM IP); UDI-DI: 00191506021252; Lot numbers: 1100687060, 1100687061; 2. UPN: 72404407 (18CM IP); UDI-DI: 00191506021276; Lot numbers: 1100676894, 1100676895;
Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.
Derived failure modes
-
Unknown
The potential for devices to experience inflation and/or deflation performance issues or difficulties.