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U.S. Department of Health and Human Services

Class 2 Device Recall AC Power Cords

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 Class 2 Device Recall AC Power Cordssee related information
Date Initiated by FirmNovember 04, 2009
Date PostedJanuary 25, 2010
Recall Status1 Terminated 3 on January 21, 2011
Recall NumberZ-0662-2010
Recall Event ID 53802
Product Classification Bed, flotation therapy, powered - Product Code IOQ
ProductAC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #4100079 used with Kinair IV Model 22600, Kinair IV 60601 Model 216050, Triadyne Proventa Model 406000, Therapulse ATP/II Models 227800 and 227080.S, Kinair Medsurg Model 201001W, and Kinair Medsurg Pulse Model 40900.
Code Information Device serial numbers affected: Kinair IV: KAPK00523 - KAPK00691; Kinair IV 60601: KAUK00001 - KAUK00134; Triadyne Proventa: TDDK0001 - TDDK00367; Therapulse ATP: TPNK00001 - TPNK00177; Kinair Medsurg: 1440-1441, KAS01524, KASK01004 - KASK02930; and Kinair Medsurg Pulse: KATK00001 - KATK00655
Recalling Firm/
Manufacturer		 KCI USA, Inc.
4958 Stout Dr
San Antonio TX 78219-4334
For Additional Information Contact
210-255-5571
Manufacturer Reason
for Recall		Power cords may crack and fail inside plug with potential for fire hazard.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionKinetics Concepts, Inc. (KCI) issued an "Urgent Medical Device Correction" letter dated November 4, 2009. Consignees were informed of the affected product and instructed to take necessary action to avoid any further issues associated with the product. For further information, contact KCI's technical support team at 1-800-275-4524 option #3.
Quantity in Commerce4,637 units
DistributionNationwide and Canada
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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