FDAClass IIJuly 7, 2021

MaxPlusTM bi fuse extension set with 2 clear needleless recall

MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injection…

Why was MaxPlusTM bi fuse extension set with 2 clear needleless recalled?

A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.

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?

Catalog Number:MP9246-C GTIN: 10885403237157 Lot Number: 20087194

Product
MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injection…
Recalling firm
CAREFUSION
Quantity
100 units
Distribution
U.S.: TN O.U.S.: None
Recall date
July 7, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls