FDA Recall Terminated

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.

Recall: Z-2439-2008 · Initiated July 29, 2008

Recall

Recall Number: Z-2439-2008
Event Number: 49110
Firm: KCI USA, Inc.
FEI Number: 1625774
Product Code: JCX
Status: Terminated
Root Cause: Equipment maintenance
Initiated: July 29, 2008
Posted: September 20, 2008
Terminated: July 13, 2009
Address: 4958 Stout Dr, San Antonio, TX, 78219-4334

Description

Reason

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.

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.

Distribution

Worldwide Distribution --- including USA and countries of Austria, Belgium, Denmark, France, Germany, Netherlands, Sweden, and the UK.

Quantity

150,125 canisters.