FDA Medical Device Recalls (openFDA)
MAQUET Inc.: Jostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crank
- Recall number
- Z-0158-2007
- Recalling firm
- MAQUET Inc.
- Product
- Jostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crank
- Status
- Terminated
- Initiated
- 2006-09-01
- Posted
- 2006-11-07
- Terminated
- 2007-12-19
- Reason
- 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.
- 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
- 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
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K943803"]
- PMA numbers
- not on file
- Product code
- DTQ
- Firm FEI
- 3008355164
- Firm city
- Bridgewater
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28