FDA Medical Device Recalls (openFDA)
KCI USA, Inc.: 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 number
- Z-2439-2008
- Recalling firm
- KCI USA, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2008-07-29
- Posted
- 2008-09-20
- Terminated
- 2009-07-13
- 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.
- Root cause
- 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
- 150,125 canisters.
- Distribution
- Worldwide Distribution --- including USA and countries of Austria, Belgium, Denmark, France, Germany, Netherlands, Sweden, and the UK.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K063740"]
- PMA numbers
- not on file
- Product code
- JCX
- Firm FEI
- 1625774
- Firm city
- San Antonio
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28