FDAClass IINovember 14, 2018

PCEA Kit ASV Yellow Stripe Microbore recall

PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification…

Why was PCEA Kit ASV Yellow Stripe Microbore recalled?

The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.

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?

Batch numbers: 16127933 17017602 17055977 17117153 17125385 18015788

Product
PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification…
Recalling firm
Becton Dickinson & Company
Quantity
566,737 total
Distribution
Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MO, MT, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and Guam. The products were distributed to the following foreign countries: Canada, United Arab Emirates and Saudi Arabia.
Recall date
November 14, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls