FDA Device Recall Z-0038-05: Kinetic Concepts, Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0038-05.

Recall Res Number

Z-0038-05

Recalling Firm / Manufacturer

Kinetic Concepts, Inc

FEI Number

1625774

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2004-09-21

Date Posted

2004-10-22

Date Terminated

2005-06-07

Product Code

JCX

Event Number

30212

Product Quantity

29610 units

Product Description V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78230

Reason for Recall The seal on the dressing pouch may open during shipping and sterility of the dressing may be compromised.

Action Details The firm initiated the recall by letter and phone calls on September 21, 2004.

Distribution Pattern The product was distributed to hospitals and clinics nationwide. The product was also shipped to the following foreign countries: Australia, Austria, Belgium, Canada, Denmark, France, Germany, Greece, Qatar, Phillipines, United Arab Emirates, Ireland, Italy, Netherlands, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

Code Information / Serial Numbers Part M6275043-5: 01.27.04.21v; 01.27.04.22v; 01.27.04.23v; 02.23.04.03; 05.06.04.07; 05.17.04.01; 05.20.04.08; 06.23.04.12; 07.07.04.13; and 08.11.04.04 Part M6275065-5: 11.06.03.01V; 11.06.03.02V; 11.06.03.03V; 11.21.03.15; 12.01.03.25; 12.15.03.14; 12.18.03.07; 01.16.04.09; 01.08.04.10; 01.20.04.10; 12.15.03.14; 02.04.04.23; 01.21.04.24; 02.09.04.22; 02.23.04.07; 03.30.04.13; 03.22.04.10; 05.04.04.08; 05.14.04.04; 05.26.04.09; 06.02.04.07; 06.04.04.15; 06.17.04.12; 07.07.04.11; 07.07.04.12; 07.20.04.14; 07.30.04.03; and 08.03.04.06

Related Establishments / Registrations

DEROYAL INDUSTRIES, INC. Registration: 1043214 View Registration
DeRoyal Industries, Inc. Registration: 1054241 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1055236 View Registration
TESSY PLASTICS CORP. Registration: 1317202 View Registration
ZIMMER SURGICAL, INC. Registration: 1526350 View Registration
Allied Medical LLC Registration: 1924066 View Registration
SSCOR, INC. Registration: 2022724 View Registration
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR Registration: 2029214 View Registration
ULTRAVIOLET DEVICES, INC. Registration: 2031894 View Registration
MADA MEDICAL PRODUCTS, INC. Registration: 2225311 View Registration
Isomedix Operations Inc. Registration: 2246552 View Registration
NBS GROUP SUPPLY- MEDICAL PRODUCTS DIVISION, LLC Registration: 2249651 View Registration
DEROYAL INDUSTRIES, INC. Registration: 2320762 View Registration
CPAC Equipment, Inc. Registration: 2431273 View Registration
DeVilbiss Healthcare LLC. Registration: 2515872 View Registration
SPARTRONICS STRONGSVILLE, INC. Registration: 3003144120 View Registration
NPA de México S. de R.L. de C.V. Registration: 3003542872 View Registration
Vaupell Midwest Molding and Tooling Registration: 3003595343 View Registration
CANADIAN HOSPITAL SPECIALTIES LTD Registration: 3003627840 View Registration
EMG TECHNOLOGY CO., LTD. Registration: 3003803075 View Registration
KMI IMI GROUP / DBA: INNOVATIVE MED, INC. Registration: 3004112621 View Registration
Kimball Electronics - Indianapolis Registration: 3004598644 View Registration
LAERDAL MEDICAL (SUZHOU) CO., LTD. Registration: 3004993040 View Registration
PENUMBRA, INC. Registration: 3005168196 View Registration
BLACK & BLACK SURGICAL, INC. Registration: 3006142527 View Registration
ACARE TECHNOLOGY CO., LTD. Registration: 3006395447 View Registration
SUNSET HEALTHCARE SOLUTIONS, Inc. Registration: 3006446479 View Registration
Viant Mexicana de Servicios, S. de R.L. de C.V. Registration: 3006535925 View Registration
Anest Iwata Sparmax Co., Ltd. Registration: 3006789357 View Registration
TAIWAN ADVANCED STERILIZATION TECHNOLOGY INC. Registration: 3007127244 View Registration
HOSPITECH RESPIRATION Registration: 3007682555 View Registration
STRYKER MANUFACTURING KALAMAZOO Registration: 3007997036 View Registration
FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. Registration: 3008220943 View Registration
SEACOLE-CRC, LLC Registration: 3008363932 View Registration
MicroVention Costa Rica S.R.L. Registration: 3010079067 View Registration
Sunset Healthcare Solutions Central Warehouse Registration: 3010834934 View Registration
PNEO, LLC Registration: 3011418975 View Registration
Zimmer Biomet Taiwan Co., Ltd. Registration: 3011683674 View Registration
COMPASS HEALTH BRANDS (CORPORATE OFFICE) Registration: 3012316249 View Registration
SANICURE BV Registration: 3012494290 View Registration
Stryker US Supply Chain Operations Registration: 3012497308 View Registration
MicroVention, Inc. Registration: 3013556777 View Registration
PFM Medical, Inc Registration: 3013666218 View Registration
Penumbra Inc. Registration: 3013758550 View Registration
TAIWAN BIOMATERIAL Company, Ltd. Registration: 3014590707 View Registration
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD Registration: 3014810929 View Registration
Zimmer (Shanghai) Medical International Trading Co., Ltd. Registration: 3015207155 View Registration
Zimmer Biomet Korea Ltd. Registration: 3015542154 View Registration
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR Registration: 3015550451 View Registration
Penumbra Inc. Registration: 3015615738 View Registration
Stryker Instruments Registration: 3015967359 View Registration
Penumbra Inc. Registration: 3016591327 View Registration
Schneider ASR B.V. Registration: 3016678045 View Registration
Quasar Medical Tecate, S.A. de C.V Registration: 3021009035 View Registration
SUNSET HEALTHCARE SOLUTIONS Warehouse Registration: 3021244152 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3025603301 View Registration
AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration
Medline ReNewal Registration: 3032391 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3033509898 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3036756245 View Registration
Canadian Hospital Specialties Ltd. Registration: 8022210 View Registration
RICHARD WOLF GMBH Registration: 9611102 View Registration
Sterigenics EO Canada, Inc. Registration: 9611665 View Registration
VEGA TECHNOLOGIES INC. Registration: 9616843 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0038-05

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer