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U.S. Department of Health and Human Services

Class 2 Device Recall Pulstar(R) DVT PREVENTION SYSTEM

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  Class 2 Device Recall Pulstar(R) DVT PREVENTION SYSTEM see related information
Date Initiated by Firm October 12, 2011
Date Posted November 14, 2011
Recall Status1 Terminated 3 on March 30, 2012
Recall Number Z-0183-2012
Recall Event ID 60122
510(K)Number K961405  
Product Classification Sleeve, limb, compressible - Product Code JOW
Product Pulstar(R) DVT PREVENTION SYSTEM, Anti-Embolism Wrap System, albahealth(R), A Subsidiary of Encompass Group, LLC.

Prevention of DVT.
Code Information Lot Numbers: 210086, 210128, 210149, 210177, 210198, and 210233
Recalling Firm/
Manufacturer		 Albahealth LLC
425 N Gateway Ave
Rockwood TN 37854-2336
For Additional Information Contact Patrick Frank
865-354-5229
Manufacturer Reason
for Recall		 The wrap portion of the device was tearing at the seam.
FDA Determined
Cause 2		 Component change control
Action Albahealth, L.L.C. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 19, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory and to quarantine all affected product. A response form was enclosed for customers to complete and return. The firm provide information on how to return the affected product and receive replacement product. Questions concerning this recall are directed to call 865-354-5229 for assistance.
Quantity in Commerce 2,582 pairs
Distribution Nationwide Distribution- including the states of CA, CO, FL, GA, IN, KY, LA, NY, OH, PA, TX, and TN.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = JOW and Original Applicant = ALBA-WALDENSIAN, INC.
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