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U.S. Department of Health and Human Services

Class 2 Device Recall 500 mL InfoV.A.C. Canister

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  Class 2 Device Recall 500 mL InfoV.A.C. Canister see related information
Date Initiated by Firm July 29, 2008
Date Posted September 20, 2008
Recall Status1 Terminated 3 on July 13, 2009
Recall Number Z-2440-2008
Recall Event ID 49110
510(K)Number K063740  
Product Classification Ac-Powered Suction Apparatus - Product Code JCX
Product 500 mL InfoV.A.C. Canister (without Gel); Part #M8275071/5 (5 canister pack) and Part #M8275071/10 (10 canister pack); products are single use and labeled as STERILE; distributed by Kinetic Concepts, Inc., San Antonio, TX.
Code Information For M8275071/5: 20063928   For M8275071/10: 20062500, 20063927, 20063927.15108D, 20063930, 20063930.15108D, 20067296, 20067297, 20067298, 20069122, 20069123, 20069123.15108D, 20069124, 20069124.15108D, 20069276, 20071227, 20073941, 20075083, 20075267, 20079189, 20079190, 20079191, 20089714, and 20094198
Recalling Firm/
Manufacturer
KCI USA, Inc.
4958 Stout Dr
San Antonio TX 78219-4334
For Additional Information Contact
210-255-5571
Manufacturer Reason
for Recall
The port on the 500mL InfoV.A.C. Canister that connects to the suction pump tubing was found to be partially or fully occluded with plastic.
FDA Determined
Cause 2
Equipment maintenance
Action Urgent - Medical Device Recall letters were sent within the US on 07/29/08 via UPS next day delivery service and a return receipt was maintained to demonstrate delivery of the recall to all consignees. Additionally, firm is sending representatives into accounts which received more than three sales units of canisters and to all foreign consignee locations to facilitate quarantine and replacement of affected stock. Consignees asked to confirm that adequate flow is being delivered and that the dressing is being drawn down for those patients currently using the InfoV.A.C. Canisters. Also, consignees are to locate and quarantine all packaged 500 ml canisters without the green inspection stickers from within the affected lot numbers in their inventory. A KCI Rep will contact them to help facilitate this process. Consignees are to complete and return the Recall Acknowledgement and Inventory Accounting Form. KCI will replace any affected product at their facility and arrange for the return of any affected product.
Quantity in Commerce 79,275 canisters.
Distribution Worldwide Distribution --- including USA and countries of Austria, Belgium, Denmark, France, Germany, Netherlands, Sweden, and the UK.
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JCX and Original Applicant = KCI USA, INC.
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