Recall Z-0183-2012 ยท JOW Sleeve, Limb, Compressible
Albahealth LLC
Pulstar(R) DVT PREVENTION SYSTEM, Anti-Embolism Wrap System, albahealth(R), A Subsidiary of Encompass Group, LLC. Prevention of DVT.
| Date | Nov 14, 2011 (initiated Oct 12, 2011) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961405 | ALBA HEALTH PAS WRAP SYSTEM Alba-Waldensian, Inc., Dec 26, 1996 |