Recall Z-2408-2024
Canadian Hospital Specialties Ltd. · initiated June 11, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
Codes / lots: Product code: 20400161S; UDI/DI: 00628725004358 (Pouch), 50628725004353 (Case of 10); Lot: 185198; Expiry: 2028-10-0.
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.
FDA-determined cause: Under Investigation by firm
Action taken
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 recalls@chsltd.com Monday through Friday from 8:30 am to 4:30 pm Eastern.
Details
- Recall number
- Z-2408-2024
- Initiated
- June 11, 2024
- Posted by FDA
- July 17, 2024
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Quantity
- 6300 units
- Distribution
- US Nationwide distribution in the state of MA.
- Recalling firm
- Canadian Hospital Specialties Ltd., Oakville