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Terminated

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

FDA Recall Z-0183-2012 · Posted 2011-11-14

Recalling FirmAlbahealth LLC
Recall StatusTerminated
Product CodeJOW
Date Initiated2011-10-12
Date Terminated2012-03-30
Product Quantity2,582 pairs

Reason for Recall

The wrap portion of the device was tearing at the seam.

Firm 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.

Root Cause

Component change control

Distribution Pattern

Nationwide Distribution- including the states of CA, CO, FL, GA, IN, KY, LA, NY, OH, PA, TX, and TN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K961405ALBA HEALTH PAS WRAP SYSTEMAlba-Waldensian, Inc. · 1996-12-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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