Z-0158-2007

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

Name: Z-0158-2007 Jostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crank
Creator: MAQUET Inc.
Published: 2006-09-01
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2006-09-01 / Terminated

FDA source

MAQUET Inc. began a recall of Jostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crank on 2006-09-01. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0158-2007
Status: Terminated
Initiated: 2006-09-01
Posted: 2006-11-07
Terminated: 2007-12-19
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Jostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crank
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: 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.
FDA root cause: Other
Action: The firm sent a safety alert letter on 9/13/06 to all US customers by Federal Express Return Receipt.
Quantity in commerce: 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.
Distribution: worldwide
Product codes and lots: 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.

Product code DTQ

K943803Class IIJostra Hl-20 Integrated Perfusion SystemJanus Biomedical, Inc. / cleared 1996-01-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)