Z-0183-2012

Pulstar(R) DVT PREVENTION SYSTEM, Anti-Embolism Wrap System, albahealth(R), A Subsidiary of Encompass Group...

Name: Z-0183-2012 Pulstar(R) DVT PREVENTION SYSTEM, Anti-Embolism Wrap System, albahealth(R), A Subsidiary of Encompass Group...
Creator: Albahealth LLC
Published: 2011-10-12
License: https://open.fda.gov/license/

Albahealth, LLC / initiated 2011-10-12 / Terminated

FDA source

Albahealth LLC began a recall of Pulstar(R) DVT PREVENTION SYSTEM, Anti-Embolism Wrap System, albahealth(R), A Subsidiary of Encompass Group, LLC. Prevention of DVT on 2011-10-12. The reason FDA records is "The wrap portion of the device was tearing at the seam". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0183-2012
Status: Terminated
Initiated: 2011-10-12
Posted: 2011-11-14
Terminated: 2012-03-30
Recalling firm: Albahealth, LLC
Product: Pulstar(R) DVT PREVENTION SYSTEM, Anti-Embolism Wrap System, albahealth(R), A Subsidiary of Encompass Group, LLC. Prevention of DVT.
Product code: JOW Sleeve, Limb, Compressible
Reason for recall: The wrap portion of the device was tearing at the seam.
FDA root cause: 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.
Product codes and lots: Lot Numbers: 210086, 210128, 210149, 210177, 210198, and 210233

Product code JOW

K961405Class IIAlba Health Pas Wrap SystemAlba-Waldensian, Inc. / cleared 1996-12-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)