Reported Jun 13, 2018 · Terminated
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992
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 · 07004-3206
Is this the product you have?
- Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992
- Lot codes and dates
Batch Number 3000018640UDI Code 10607567205373Batch Number 3000020516UDI Code 10607567205373
- Amount recalled
- 19 total kits
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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