Reported Sep 10, 2014 · Terminated
LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group
Datascope Corporation
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Datascope Corporation · 15 Law Dr · Fairfield, NJ · 07004-0011
Is this the product you have?
- LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group
- Lot codes and dates
- Part Number - 0684-00-0480-01U
- Amount recalled
- one unit
Where it was sold
Why it was recalled
During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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