High Flow Insufflation Tubing Recalled for Incomplete Seals
Canadian Hospital Specialties is recalling HIGH FLOW INSUFFLATION TUBING with incomplete seals that may result in non-sterile product. The defect affects 6,300 units and poses patient safety concerns.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with confirmed manufacturing defect (incomplete seals) that directly compromises sterility of a surgical device used internally. No illnesses or injuries have been reported, but non-sterile surgical equipment presents direct infection risk to patients.
Plain-English summary
Canadian Hospital Specialties Ltd. is recalling HIGH FLOW INSUFFLATION TUBING (with Filter), Model 20400161S, due to incomplete seals that can compromise product sterility. The recall affects approximately 6,300 units distributed nationwide.
The defect was discovered when a customer found product with incomplete seals in lot 185198. The manufacturer has validated this complaint. Non-sterile insufflation tubing used in laparoscopic surgical procedures presents patient safety concerns.
Consumers and healthcare providers should stop using affected units immediately. Affected products can be identified by model number 20400161S and lot 185198. For additional information or product return instructions, contact Canadian Hospital Specialties Ltd.
The recalled product
- Product
- Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
- Manufacturer
- Canadian Hospital Specialties Ltd.
- Hazard
- non-sterile
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Product code: 20400161S
- UDI/DI: 00628725004358 (Pouch)
- 50628725004353 (Case of 10)
- Lot: 185198
- Expiry: 2028-10-0.
Distribution
Distributed nationwide across the United States.
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