Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Jostra

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Jostrasee related information
Date Initiated by FirmSeptember 01, 2006
Date PostedNovember 07, 2006
Recall Status1 Terminated 3 on December 19, 2007
Recall NumberZ-0158-2007
Recall Event ID 36252
510(K)NumberK943803 
Product Classification Heart Lung Perfusion System - Product Code DTQ
ProductJostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crank
Code Information 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.
FEI Number 3008355164
Recalling Firm/
Manufacturer		 MAQUET Inc.
1140 US Highway 22
Bridgewater NJ 08807-2958
For Additional Information ContactJamie Yieh
908-947-2311
Manufacturer 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 Determined
Cause 2		Other
ActionThe firm sent a safety alert letter on 9/13/06 to all US customers by Federal Express Return Receipt.
Quantity in Commerce132 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.
Distributionworldwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = DTQ
-
-