FDA Device

Jostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crank

Hazard

The hand crank necessary for the emergency manual operation of the pump is too wide diametrically to fit into the holes which they were designed to fill.

What You Should Do

Remedy

The firm sent a safety alert letter on 9/13/06 to all US customers by Federal Express Return Receipt.

Products

Jostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crank
Brand
MAQUET Inc.
UPC
Article # 923391 The affected HL-20 base units include S/Ns 100001 through 100240. Hand cranks shipped between the dates of 8/15/05 to 8/14/06 have the potential to be defective.  Serial #s100155, 1025, 1026, 1032, 1331, 1332, 100011, 100015, 100016, 100017, 1272, 1417, 1480, 1500, 1653, 14031054, 14031055, 14031059, 14041074, 14041874, 100012, 100013, J14041874, 1584, 100108, 100109, 14041074, JOSTRA, 100009, 100010, 100130, 100131, 1625, 1626, 1627, 1628, 1629, 100135, 100136, 100137, 14031040, 14031068, 100188, 1019, 1020, 1021, 1295, 100021, 100022, 100116, 14031051, 14031052, 1507, 1508, 1509, 100017, 100219, 100220, 100221, 100222, 100223, 100224, 100225, 100226, 100227, 100228.

Units Affected

132 or less in US. Firm officials stated that 66 base units in US 8/1/05 to 8/14/06 - each units comes with 2 hand cranks.