Reported Feb 6, 2019 · Ongoing
SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use…
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?
- SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.
- Lot codes and dates
- BTC93GTIN/UDI Lot/Serial Numbers
1067397852254521569154410673978522545215691545106739785225452157372281067397852254521573722910673978522545215782206106739785225452157822071067397852254521581685910673978522545215816860106739785225452158574231067397852254521585742410673978522545215903431106739785225452159462771067397852254521624514210673978522545215875581106739785225452158755821067397852254521587558310673978522545216045172106739785225452160627201067397852254521610778810673978522545216150361106739785225452161999881067397852254521623820910673978522545216245141106739785225452163729651067397852254521637296610673978522545216372967106739785225452164212351067397852254521642123610673978522545216438179
- BTC98GTIN/UDI Lot/Serial Numbers
1067397852257621578220510673978522576215903430106739785225762160341601067397852257621606271810673978522576216238210
- BTC93GTIN/UDI Lot/Serial Numbers
- Amount recalled
- 7587 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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