Canadian Hospital Specialties Ltd.: Device Recall
Recall #Z-2408-2024 · 06/11/2024
Class II: Risk
Recall Details
- Recall Number
- Z-2408-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Canadian Hospital Specialties Ltd.
- Status
- Ongoing
- Date Initiated
- 06/11/2024
- Location
- Oakville, Canada
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6300 units
Reason for Recall
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.
Product Description
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
Distribution Pattern
US Nationwide distribution in the state of MA.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.