500 mL InfoV.A.C. Canister (without Gel); Part #M8275071/5 (5 canister pack) and Part #M8275071/10 (10 canister pack); p

FDA device recall Z-2440-2008 · posted 2008-09-20 · Terminated

Recall details

Recalling firm

KCI USA, Inc.

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.

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.

Root cause

Equipment maintenance

Status

Terminated

Product code

JCX

Quantity affected

79,275 canisters.

Distribution

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

Date initiated

2008-07-29

Date posted

2008-09-20

Date terminated

2009-07-13

Location

San Antonio, TX

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