Becton Dickinson & Company: Medical Device Recall in 2018 - (Recall #: Z-0387-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: September 26, 2018

Date Posted: November 14, 2018

Recall Number: Z-0387-2019

Event ID: 81181

Reason for Recall:

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

Status: Terminated

Product Quantity: 566,737 total

Code Information:

Batch numbers: 16127933 17017602 17055977 17117153 17125385 18015788

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated