Date Initiated by Firm | June 11, 2024 |
Date Posted | July 17, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2408-2024 |
Recall Event ID |
94834 |
510(K)Number | K001068 |
Product Classification |
Laparoscope, general & plastic surgery - Product Code GCJ
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Product | Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter)
Model/Catalog Number: 20400161S
Product Description: Laparoscopic Insufflator |
Code Information |
Product code: 20400161S; UDI/DI: 00628725004358 (Pouch), 50628725004353 (Case of 10); Lot: 185198; Expiry: 2028-10-0.
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Recalling Firm/ Manufacturer |
Canadian Hospital Specialties Ltd. 2760 Brighton Rd Oakville Canada
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Manufacturer 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 2 | Under Investigation by firm |
Action | 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. |
Quantity in Commerce | 6300 units |
Distribution | US Nationwide distribution in the state of MA. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = GCJ
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