FDA Device

SHPI LIftLoc Safety Infusion Sets

Hazard

Pouch seals on Safety Infusion Sets may be defective, possibly compromising sterility.

What You Should Do

Remedy

The single consignee (BAS) was notified by lettter on 4/14/03.

Products

SHPI LIftLoc Safety Infusion Sets
Brand
Specialized Health Products, Inc.
UPC
Product Code - Lot #: 0661934- 36ANHP01; 0662034 - 36ANHP02; 0662234 - 36ANHO03; 0661910 -36ANHP04; 0661915 - 36ANHP04; 0661915 -36ANHP06; 0662015 - 36ANHO7; 0662215 -36ANHP08; 0662010- 36ANHP09; 0641910 -36ANHP10; 0642234 -36ANHP11; 0642210 - 36ANHP12; 0641934 -36ANHP13; 0642034 -36ANHP14; 0642010 -36ANHP15; 0614915 -36ANHP16; 0642015 -36ANHP17; 0642210 -36ANHP19; 0642234 -36ANHP20; 0641910 -36ANHP21.

Units Affected

2240 units