Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) recallZ-2408-2024 · Canadian Hospital Specialties Ltd. · initiated Jun 11, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Canadian Hospital Specialties Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2408-2024
- Status
- Open, Classified
- Initiated by the company
- Jun 11, 2024
- Posted by the FDA
- Jul 17, 2024
- Recalling firm
- Canadian Hospital Specialties Ltd.
- Quantity
- 6300 units
- Product code
- GCJ
- FDA submissions
- K001068
- Distribution
- US Nationwide distribution in the state of MA.
Product description
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
Code information (models, lots, serial numbers)
Product code: 20400161S; UDI/DI: 00628725004358 (Pouch), 50628725004353 (Case of 10); Lot: 185198; Expiry: 2028-10-0.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- STORZ 20400161SCanadian Hospital Specialties Limited · Insufflator, Laparoscopic1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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