CLASS II ONGOING Device recall · Reported 24 Jul 2024 · FDA Enforcement Report
High Flow Insufflation Tubing (with Filter) recalled
Canadian Hospital Specialties is recalling High Flow Insufflation Tubing (with Filter), distributed nationwide in the US. The recall was initiated on 11 Jun 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2408-2024
- FDA event ID
- 94834
- Recalling firm
- Canadian Hospital Specialties, Oakville
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Jun 2024
- FDA classified
- 17 Jul 2024
- Reported
- 24 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 11 Jun 2024 | Recall initiated by company | |
| 17 Jul 2024 | Classified by FDA | +36 days |
| 24 Jul 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
Where it was distributed
US Nationwide distribution in the state of MA.
Questions about this recall
Why was it 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.
Which lots are affected?
Product code: 20400161S; UDI/DI: 00628725004358 (Pouch), 50628725004353 (Case of 10); Lot: 185198; Expiry: 2028-10-0.
Where was it sold?
US Nationwide distribution in the state of MA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Canadian Hospital Specialties
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|---|---|---|---|---|---|
| Device | CLASS III | Med-rx Urological Cysto/bladder Irrigation Set recalled | Canadian Hospital Specialties | Packaging Defects | N/A |
| Device | CLASS II | Med-rx Polyurethane Feeding Tubes: a) recalled | Canadian Hospital Specialties | Other | GA, TN |
| Device | CLASS II | Med-rx Polyurethane Feeding Tube For Pediatric Use recalled | Canadian Hospital Specialties | Packaging Defects | TN |
| Device | CLASS II | Med-rx, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube recalled | Canadian Hospital Specialties | Packaging Defects | GA |
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