FDAClass IIMay 20, 2020

BD Alaris PCEA Administration Set recall

BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 10800177 - Product Usage: Microbore Tubing…

Why was BD Alaris PCEA Administration Set recalled?

The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a leak in an administration set would be inadequate pain control for the patient due to an under-infusion of medication.

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?

UDI: 10885403234422; Lot Numbers: 19016200 19045273

Product
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 10800177 - Product Usage: Microbore Tubing…
Recalling firm
BD SWITZERLAND SARL
Quantity
110,350
Distribution
Worldwide distribution - US Nationwide Distribution and the countries of Canada, Belgium.
Recall date
May 20, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls