FDAClass IIAugust 27, 2014

Port Access Kit with MicroClave Clear Connector recall: Sterility Concern

Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are co-packaged into a kit with ICU devices and other…

Why was Port Access Kit with MicroClave Clear Connector recalled?

ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.

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 No. 2705203

Product
Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are co-packaged into a kit with ICU devices and other…
Recalling firm
ICU Medical, Inc.
Quantity
400 units
Distribution
Nationwide Distribution - USA including AL and MD.
Recall date
August 27, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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