High Flow Insufflation Tubing recall: Sterility Concern
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
Why was High Flow Insufflation Tubing 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product code: 20400161S; UDI/DI: 00628725004358 (Pouch), 50628725004353 (Case of 10); Lot: 185198; Expiry: 2028-10-0.
- Product
- Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
- Recalling firm
- Canadian Hospital Specialties Ltd.
- Quantity
- 6300 units
- Distribution
- US Nationwide distribution in the state of MA.
- Recall date
- July 24, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)