FDA-Device2024-07-24Class II
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
Canadian Hospital Specialties Ltd.
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.
Sold states
US Nationwide distribution in the state of MA.
Affected count
6300 units
Manufactured in
2760 Brighton Rd, Oakville, Canada
Products
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2408-2024Don't want to check this manually?
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