Recall Z-2408-2024— Canadian Hospital Specialties Ltd.
Class II · Ongoing
Class II FDA medical device recall by Canadian Hospital Specialties Ltd., initiated 2024-06-11. It names one FDA 510(k) clearance: K001068. Product: 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..
- Recalling firm
- Canadian Hospital Specialties Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-06-11
- Firm location
- Oakville, Canada
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.