Z-2408-2024Class II

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

Name: Z-2408-2024 Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product...
Creator: Canadian Hospital Specialties Ltd.
Published: 2024-06-11
License: https://open.fda.gov/license/

Canadian Hospital Specialties Ltd. / initiated 2024-06-11 / Open, Classified / root cause: sterility

FDA source

Canadian Hospital Specialties Ltd. began a recall of Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator on 2024-06-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2408-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-11
Posted: 2024-07-17
Recalling firm: Canadian Hospital Specialties Ltd.
Product: Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
Product code: GCJ Laparoscope, General & Plastic Surgery
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.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: On June 13, 2024 their only direct US consignee was sent an URGENT: MEDICAL DEVICE VOLUNTARY RECALL NOTIFICATION letter. Action to be Taken by the Customer 1. Please acknowledge receipt of this notification by completing the attached Customer Effectiveness Check form. 2. Please notify any customers who have received this product for their awareness. 3. Please notify Canadian Hospital Specialties Ltd. of any remaining affected product in your inventory by completing the Customer Response form along with the Product Destruction Verification form and return via email to Canadian Hospital Specialties Ltd. so credit can be provided. Should you have any questions or concerns, please do not hesitate to reach out to CHS directly at [email protected] Monday through Friday from 8:30 am to 4:30 pm Eastern.
Quantity in commerce: 6300 units
Distribution: US Nationwide distribution in the state of MA.
Product codes and lots: Product code: 20400161S; UDI/DI: 00628725004358 (Pouch), 50628725004353 (Case of 10); Lot: 185198; Expiry: 2028-10-0.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2408-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2408-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-17

Product code GCJ

K001068Class IINbs Connecting Tube SetNbs Products CO / cleared 2000-06-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)