Recall Z-2408-2024 ยท GCJ Laparoscope, General & Plastic Surgery
Canadian Hospital Specialties Ltd.
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
| Date | Jul 17, 2024 (initiated Jun 11, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On June 13, 2024 their only direct US consignee was sent an URGENT: MEDICAL DEVICE VOLUNTARY RECALL NOTIFICATION letter. Action to be Taken by the Customer 1. Please acknowledge receipt of this notification by completing the attached Customer Effectiveness Check form. 2. Please notify any customers who have received this product for their awareness. 3. Please notify Canadian Hospital Specialties Ltd. of any remaining affected product in your inventory by completing the Customer Response form along with the Product Destruction Verification form and return via email to Canadian Hospital Specialt |
| Quantity | 6300 units |
| Distribution | US Nationwide distribution in the state of MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001068 | NBS CONNECTING TUBE SET Nbs Products CO, Jun 14, 2000 |