500 mL InfoV.A.C. Canisters (with Gel); Part #M8275063/5 (5 canister pack) and Part #M8275063/10 (10 canister pack); products are single use and labeled as STERILE; distributed by Kinetic Concepts, Inc., San Antonio, TX.
This recall has been terminated (originally issued September 20, 2008).
- Company
- Kci Usa, Inc.
- Recall Initiated
- July 29, 2008
- Posted
- September 20, 2008
- Terminated
- July 13, 2009
- Recall Number
- Z-2439-2008
- Quantity
- 150,125 canisters.
- Firm Location
- San Antonio, TX
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution --- including USA and countries of Austria, Belgium, Denmark, France, Germany, Netherlands, Sweden, and the UK.
Lot / Code Info
For M8275063/5: 20064392, 20069119, 20069125, 20069126, 20069279, 20069279.18308F, 20075082, and 20079173 For M8275063/10: 20046268, 20046268.18908A, 20046270, 20063933, 20064393, 20064394, 20064395, 20064753, 20064753.14408B, 20067300, 20067300.14408B, 20067301, 20067302, 20067303, 20067304, 20067305, 20069120, 20069121, 20069273, 20069273.14408B; 20069274, 20069275, 20069275.18908A, 20069277, 20069277.18908A, 20069278, 20069278.18908A, 20069280, 20075084, 20075085, 20075086, 20075262, 20075263, 20075264, 20075265, 20075266, 20075268, 20075269, 20079174, 20079175, 20079176, 20079177, 20079178, 20079179, 20079180, 20079181, 20079182, 20079183, 20079184, 20079185, 20079186, 20079187, 20079188, 20089680, 20089681, 20089682, 20089712, 20089713, 20089749, 20089750, 20093372, 20093374, and 20094200
Root Cause
Equipment maintenance
Action Taken
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.