Class II

Medical Device Recall: Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator

Canadian Hospital Specialties Ltd. · June 11, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

6300 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2408-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.