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Terminated

RAD SOURCE RS 3000 Blood Irradiator Three Bag Option

FDA Recall Z-0745-04 · Posted 2004-07-20

Recalling FirmRad-Source Technologies, Inc.
Recall StatusTerminated
Product CodeMOT
Date Initiated2002-06-01
Date Terminated2012-05-03
Product Quantity20

Reason for Recall

The firm completed a cooling system retrofit to preclude overheating and failure.

Firm Action

The firm e-mailed a notification on May 9, 2002 to its consignees giving them instructions on using additional radiation indictors to assure that the blood units were correctly irradiated. They also initiated a cooling tube retrofit of all units on that date and this was completed on 8/13/2002.

Root Cause

Other

Distribution Pattern

Units were distributed to 20 blood banks and transfusion services in WI, KS, IN, MI, GA, NC, WA, NE, FL, IN, TX, MD, Washington DC, SC, and NM.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K974210SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000Rad-Source, Inc. · 1998-03-30

Official Source

View FDA Recall →

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

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