Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
Recall
- Recall Number
- Z-2408-2024
- Event Number
- 94834
- Firm
- Canadian Hospital Specialties Ltd.
- FEI Number
- 3932
- Product Code
- GCJ
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- June 11, 2024
- Posted
- July 17, 2024
- Address
- 2760 Brighton Rd, Oakville Canada
Description
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
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.
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.
US Nationwide distribution in the state of MA.
6300 units