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U.S. Department of Health and Human Services

Class 2 Device Recall Storz Disp High Flow Insufflation Tbg w/Filter 20400161S

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 Class 2 Device Recall Storz Disp High Flow Insufflation Tbg w/Filter 20400161Ssee related information
Date Initiated by FirmJune 11, 2024
Date PostedJuly 17, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2408-2024
Recall Event ID 94834
510(K)NumberK001068 
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
ProductProduct 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.
Recalling Firm/
Manufacturer
Canadian Hospital Specialties Ltd.
2760 Brighton Rd
Oakville Canada
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
ActionOn 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 Commerce6300 units
DistributionUS Nationwide distribution in the state of MA.
Total Product Life CycleTPLC Device Report

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.
510(K) Database510(K)s with Product Code = GCJ
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