Canadian Hospital Specialties Ltd. Recall 94834
Description: Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
Canadian Hospital Specialties Ltd. Recall 94834 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2408-2024 |
| Event ID | 94834 |
| Event Description | Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of MA. |
| Quantity | 6300 units |
| Recall 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. |
| Device Classification | 20240724 |
| Device Code Info | Product code: 20400161S; UDI/DI: 00628725004358 (Pouch), 50628725004353 (Case of 10); Lot: 185198; Expiry: 2028-10-0. |
| Center Classification Date | 20240717 |
| Recall Initiation Date | 20240611 |
| Recalling Firm | Canadian Hospital Specialties Ltd. |
| Initial Notification | Letter |
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