FDA recall Z-2408-2024

Canadian Hospital Specialties Ltd. · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2024-06-11
Report date
2024-07-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Oakville, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2408-2024