FDA Device recall Z-2408-2024
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
- FDA Device
- Class II
- ongoing
- Published 2024-07-24
On 2024-07-24 the FDA classified a Class II recall of Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator by Canadian Hospital Specialties, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2408-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-11 |
| Published | 2024-07-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Canadian Hospital Specialties |
| Distribution | US |
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.
Identifiers
| code_info | Product code: 20400161S; UDI/DI: 00628725004358 (Pouch), 50628725004353 (Case of 10); Lot: 185198; Expiry: 2028-10-0. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2408-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.