FDAClass IFebruary 24, 2021

Fresh Whole Blood Donor Set recall

Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains everything needed to…

Why was Fresh Whole Blood Donor 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: MFG2977, MFG2991, MFG3073, MFG3118, MFG3279, MFG3328, MFG3332, MFG3337, MFG3339, MFG3499, MFG3507, MFG3512, MFG3533, MFG3704, MFG3751, MFG3761, MFG3760, MFG3857

Product
Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains everything needed to…
Recalling firm
Combat Medical Systems, LLC
Quantity
954 units
Distribution
US Nationwide Distribution
Recall date
February 24, 2021
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls