Canadian Hospital Specialties product recalled over sterility concerns

Recall date

June 11, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

Z-2408-2024

FDA classification

Class II

Brand / firm

Canadian Hospital Specialties Ltd.

Sold / distributed

US Nationwide distribution in the state of MA.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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