Z-0387-2019Class II

PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177

Name: Z-0387-2019 PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177
Creator: Becton Dickinson & Company
Published: 2018-09-26
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2018-09-26 / Terminated

FDA source

Becton Dickinson & Company began a recall of PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe... on 2018-09-26. FDA classified it as Class II and gives the reason as "The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0387-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-26
Posted: 2018-11-04
Terminated: 2020-04-13
Recalling firm: Becton Dickinson & Co
Product: PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 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. Push on syringe plunger to prime set. 3. Refer to PCA module directions for Use for complete loading and operating instructions. Notes: The set should be changed according to the facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.
Product code: FPA Set, Administration, Intravascular
Reason for recall: The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.
FDA root cause: Under Investigation by firm
Action: The initial recall letters were sent out to customers on September 26, 2018. An update was sent to customer on October 5, 2018 that included additional lots. The letters identified the affected product, problem and actions to be taken. Contact Information: For BD Support Center contact Phone: 888-562-6018 Email: [email protected] For Customer Advocacy Phone: 888-812-3266 Email: [email protected]
Quantity in commerce: 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.
Product codes and lots: Batch numbers: 16127933 17017602 17055977 17117153 17125385 18015788

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0387-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0386-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-03
Z-0387-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-03

Product code FPA

K811885Class II30-30-2 700 Syringe Extension SetY / cleared 1981-08-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)