Source: FDA Enforcement Report, July 27.
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a) HomeChoice Automated Peritoneal Dialysis Systems; Made in U.S.A.; catalog numbers 5C4471,5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R,
Recall # Z-1018-05;
b) HomeChoice PRO Automated Peritoneal Dialysis Systems; Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R, Recall # Z-1019-05
All serial numbers.
Recalling Firm: Baxter Healthcare Renal Division, McGaw Park, IL, by letters on June 21, 2005 and June 22, 2005.
Manufacturer: Baxter Healthcare Corporation, Largo, FL. Firm initiated recall is ongoing.
The screws that secure the Power Entry Module (PEM) to the base of the HomeChoice device are not reliably grounded to the device's ground system, posing an electric shock hazard.
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally