FDAClass IFebruary 24, 2021

Low Titer Type O FWB Transfusion Set recall

Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to…

Why was Low Titer Type O FWB Transfusion Set recalled?

There is the potential of a bent or disconnected needle in one of the components of the convenience kits.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Lot Numbers: MFG2267, MFG2347, MFG2375, MFG2430, MFG2538, MFG2637, MFG2655, MFG2693, MFG2708, MFG2754, MFG2828, MFG3120, MFG3186, MFG3340, MFG3378, MFG3386, MFG3586, MFG3640

Product
Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to…
Recalling firm
Combat Medical Systems, LLC
Quantity
1021 units
Distribution
US Nationwide Distribution
Recall date
February 24, 2021
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls