Pulstar(R) DVT PREVENTION SYSTEM, Anti-Embolism Wrap System, albahealth(R), A Subsidiary of Encompass Group, LLC. Preven
FDA device recall Z-0183-2012 · posted 2011-11-14 · Terminated
Recall details
- Recalling firm
- Albahealth LLC
- Reason for recall
- The wrap portion of the device was tearing at the seam.
- Action taken
- 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.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- JOW
- Quantity affected
- 2,582 pairs
- Distribution
- Nationwide Distribution- including the states of CA, CO, FL, GA, IN, KY, LA, NY, OH, PA, TX, and TN.
- Date initiated
- 2011-10-12
- Date posted
- 2011-11-14
- Date terminated
- 2012-03-30
- Location
- Rockwood, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALBA HEALTH PAS WRAP SYSTEM (K961405) | Alba-Waldensian, Inc. | 1996-12-26 |