FDAClass IIOctober 16, 2019

CVC Insertion Bundle 8.5fr 4l 16cm Ecvc6355 recall

CVC INSERTION BUNDLE 8.5FR 4L 16CM ECVC6355

Why was CVC Insertion Bundle 8.5fr 4l 16cm Ecvc6355 recalled?

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

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?

2018030250 2018072750 2018090450 2018091750 2018122650 2019011050 2019020450 2019031350 2019040150

Product
CVC INSERTION BUNDLE 8.5FR 4L 16CM ECVC6355
Recalling firm
Centurion Medical Products Corporation
Quantity
181965 total
Distribution
Nationwide domestic distribution.
Recall date
October 16, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls