FDA Medical Device Recalls (openFDA)
Albahealth LLC: Pulstar(R) DVT PREVENTION SYSTEM, Anti-Embolism Wrap System, albahealth(R), A Subsidiary of Encompass Group, LLC. Prevention of DVT.
- Recall number
- Z-0183-2012
- 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.
- Status
- Terminated
- Initiated
- 2011-10-12
- Posted
- 2011-11-14
- Terminated
- 2012-03-30
- Reason
- The wrap portion of the device was tearing at the seam.
- 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
- 2,582 pairs
- Distribution
- Nationwide Distribution- including the states of CA, CO, FL, GA, IN, KY, LA, NY, OH, PA, TX, and TN.
- Lot, serial or model codes
- Lot Numbers: 210086, 210128, 210149, 210177, 210198, and 210233
- 510(k) numbers
- ["K961405"]
- PMA numbers
- not on file
- Product code
- JOW
- Firm FEI
- 1043612
- Firm city
- Rockwood
- Firm state
- TN
- 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