Recall Z-0387-2019 ยท FPA Set, Administration, Intravascular
Becton Dickinson & Company
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 instr
| Date | Sep 26, 2018 |
| Status | Terminated |
| Reason | The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing. |
| 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: SupportCenter@CareFusion.com For Customer Advocacy Phone: 888-812-3266 Email: customerfeedback@bd.com |
| 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 Ar |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K811885 | 30-30-2 700 SYRINGE EXTENSION SET Y, Aug 25, 1981 |