Reservoir "y" Adapter recall
RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the…
Why was Reservoir "y" Adapter 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
BT920: GTIN/UDI Lot/Serial Numbers 10673978522460 216044420 10673978522460 216062719 10673978522460 216438180 BT926: GTIN/UDI Lot/Serial Numbers 10673978522477 215782209 10673978522477 215903433 10673978522477 216034158 10673978522477 216107790 10673978522477 216372963 10673978522477 216438301
- Product
- RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the…
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 1100 units
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Japan, and Sweden.
- Recall date
- February 6, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)