Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product code: 20400161S; UDI/DI: 00628725004358 (Pouch), 50628725004353 (Case of 10); Lot: 185198; Expiry: 2028-10-0.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Canadian Hospital Specialties Ltd.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
Product Codes/Lot Numbers:
Product code: 20400161S; UDI/DI: 00628725004358 (Pouch), 50628725004353 (Case of 10); Lot: 185198; Expiry: 2028-10-0.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2408-2024
Related Recalls
MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
Canadian Hospital Specialties
Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible barcode which prevents successful scanning of the package.
MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16" (40cm), REF 54-1665R c) 5Fr X 24" (60cm), REF 54-2450R d) 6.5Fr X 24" (60cm), REF 54-2465R e) 8Fr X 24: (60cm), REF 54-2480R f) 8Fr X 36" (91cm), REF 54-3680R
Canadian Hospital Specialties
The firm received a complaint that the connector detached from the feeding tube.
The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feeding tube as labeled.