Reported Feb 6, 2019 · Ongoing
RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with an…
Medtronic Perfusion Systems
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: Medtronic Perfusion Systems · 7611 Northland Dr N · Brooklyn Park, MN · 55428-1088
Is this the product you have?
- RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.
- Lot codes and dates
- BT920GTIN/UDI Lot/Serial Numbers 10673978522460 216044420 10673978522460 216062719 10673978522460 216438180
- BT926GTIN/UDI Lot/Serial Numbers
106739785224772157822091067397852247721590343310673978522477216034158106739785224772161077901067397852247721637296310673978522477216438301
- Amount recalled
- 1100 units
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
- Nationwide
Why it was recalled
Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the Y-connectors to leak when in use, which could result in potential blood loss and a breach in the circuit.
This product could cause temporary or reversible health problems — stop using it.
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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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