Device product
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
Z-2408-2024
Product summary
- Event
- Event 94834
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6300 units
- Official record key
device-enforcement:Z-2408-2024
Official wording
Reason: A customer found product with incomplete seals of P/N 20400161S, lot #185198 which can lead to non-sterile product and patient safety concerns. CHS has validated this complaint.
Code information: Product code: 20400161S; UDI/DI: 00628725004358 (Pouch), 50628725004353 (Case of 10); Lot: 185198; Expiry: 2028-10-0.
Distribution pattern: US Nationwide distribution in the state of MA.
Derived failure modes
-
Unknown
A customer found product with incomplete seals of P/N 20400161S, lot #185198 which can lead to non-sterile product and patient safety concerns. CHS has validated this complaint.