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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMay 20, 2005
Date PostedAugust 03, 2005
Recall Status1 Terminated 3 on October 03, 2006
Recall NumberZ-1061-05
Recall Event ID 32267
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
ProductPolystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter).
Code Information Lot numbers: 162119; 162572; 163299; 164050; 165934; 167444; 167446; 171658; 176841; 178282; 179626; 180352; 180822; 184419; 185618; 186149; 187100; 188865.
FEI Number 3008355164
Recalling Firm/
Manufacturer		 Maquet Inc
1140 Route 22 East
Bridgewater NJ 08807-2912
For Additional Information ContactJamie Yieh
908-947-2311
Manufacturer Reason
for Recall		Upon acquisition of Jostra AG, manufacturer of Polystan Coronary Cannula Balloon Tip Catheters, Maquet was unable to confirm the catheter's FDA approval status.
FDA Determined
Cause 2		Other
ActionMaquet Cardiopulmonary AG, Germany through their US firm Maquet, Inc. notified Surgemedical, Inc to return all cannula identified with the Ref. Number 22xxxx back to Maquet Cardiopulmonary.
Quantity in Commerce890 units
DistributionNationwide. Maquet Cardiopulmonary AG, Hirrlingen, Germany has one US distributor, Surgemedical Inc., Holland, Michigan. The firm is to return all cannula in their possession back to Maquet.
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.
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