Z-0387-2019 Class II Terminated
FDA device recall Z-0387-2019 was initiated by Becton Dickinson & Company on Sep 26, 2018 and is designated Class II. Reason for recall: The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing. The recall status is terminated (terminated Apr 13, 2020). Affected quantity: 566,737 total.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 14, 2018
- Initiation Date
- Sep 26, 2018
- Termination Date
- Apr 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 566,737 total
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.
Reason for Recall
The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.
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.
Code Information
Batch numbers: 16127933 17017602 17055977 17117153 17125385 18015788
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0387-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026