FDA Enforcement
Class II
Ongoing
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
Recall: Z-2408-2024
·
Reported July 24, 2024
Enforcement
- Recall Number
- Z-2408-2024
- Event ID
- 94834
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Canadian Hospital Specialties Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 24, 2024
- Initiation Date
- June 11, 2024
- Classification Date
- July 17, 2024
- Address
- 2760 Brighton Rd, Oakville, N/A, Canada
Description
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
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 Info
Product code: 20400161S; UDI/DI: 00628725004358 (Pouch), 50628725004353 (Case of 10); Lot: 185198; Expiry: 2028-10-0.
Distribution
US Nationwide distribution in the state of MA.
Quantity
6300 units