Reported Oct 19, 2016 · Terminated
The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit…
Circulatory Technology Inc.
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: Circulatory Technology Inc · 21 Singworth St · Oyster Bay, NY · 11771-3703
Is this the product you have?
- The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
- Lot codes and dates
- Lot Numbers
R19229015323014882014602 & 014601
- Lot Numbers
- Amount recalled
- 958 units
Where it was sold
Why it was recalled
Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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