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
    • 10673978522545
    • 215691544
    • 10673978522545
    • 215691545
    • 10673978522545
    • 215737228
    • 10673978522545
    • 215737229
    • 10673978522545
    • 215782206
    • 10673978522545
    • 215782207
    • 10673978522545
    • 215816859
    • 10673978522545
    • 215816860
    • 10673978522545
    • 215857423
    • 10673978522545
    • 215857424
    • 10673978522545
    • 215903431
    • 10673978522545
    • 215946277
    • 10673978522545
    • 216245142
    • 10673978522545
    • 215875581
    • 10673978522545
    • 215875582
    • 10673978522545
    • 215875583
    • 10673978522545
    • 216045172
    • 10673978522545
    • 216062720
    • 10673978522545
    • 216107788
    • 10673978522545
    • 216150361
    • 10673978522545
    • 216199988
    • 10673978522545
    • 216238209
    • 10673978522545
    • 216245141
    • 10673978522545
    • 216372965
    • 10673978522545
    • 216372966
    • 10673978522545
    • 216372967
    • 10673978522545
    • 216421235
    • 10673978522545
    • 216421236
    • 10673978522545
    • 216438179
  • BTC98GTIN/UDI Lot/Serial Numbers
    • 10673978522576
    • 215782205
    • 10673978522576
    • 215903430
    • 10673978522576
    • 216034160
    • 10673978522576
    • 216062718
    • 10673978522576
    • 216238210
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:16 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.