FDAClass IIDecember 7, 2016

Sterile IV Start Kits 50 units/trays per case recall: Sterility Concern

Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures

Why was Sterile IV Start Kits 50 units/trays per case recalled?

Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot.

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 Number 361105, exp date 1/01/2017, Product Catalog Number 375198

Product
Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures
Recalling firm
B. Braun Medical, Inc.
Quantity
15,950 units
Distribution
Nationwide Distribution to GA, IL, and FL
Recall date
December 7, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls