Reported Mar 7, 2018 · Terminated
Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold…
Circulatory Technology Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
- Better-Bladder cardiopulmonary bypass blood reservoir
- ModelsBB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)
- Lot codes and dates
- **Recall expanded to add additional lot numbers highlighted with "**":
- BB14 Lot Numbers
5290-S197855290-S197865290-S19872**5290-S19925
- BB14NS Lot Numbers
170622011706220217062203and **170905
- Amount recalled
- 840
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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