Canadian Hospital Specialties Ltd.: Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator

Hazard

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.

Details from the source

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. Distribution: US Nationwide distribution in the state of MA. Quantity: 6300 units Lot/code info: Product code: 20400161S; UDI/DI: 00628725004358 (Pouch), 50628725004353 (Case of 10); Lot: 185198; Expiry: 2028-10-0.

UPC codes

00628725004358, 50628725004353

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.