The Recall Desk
HighFDA (Devices)·Z-0386-2019·Announced 2018-11-14

Becton Dickinson Recalls PCEA ASV Yellow Microbore Administration Sets

Becton Dickinson is recalling PCEA ASV Yellow Microbore administration sets because they may leak at the luer lock connection.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential leak in a medical device used for patient care, which poses a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

Becton Dickinson & Company is recalling PCEA ASV Yellow Microbore administration sets, catalog numbers 30893 and 30893-07. The recall involves 566,737 units distributed worldwide, including nationwide in the United States and in Canada, the United Arab Emirates, and Saudi Arabia.

The FDA classified this as a Class II recall because the products have the potential to leak between the connection of the male luer lock and the yellow striped tubing. This defect could compromise the integrity of the administration set used for patient care.

Healthcare facilities should stop using the affected products and contact Becton Dickinson for instructions on how to return or dispose of them. Patients should consult their healthcare provider if they have questions regarding the use of these specific administration sets.

The recalled product

Product
PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. Connect PCA syringe to female luer on administration set. 2.
Affected units
566,737

Distribution

Distributed nationwide across the United States.

The notice also names 38 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Becton Dickinson & Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →