Device 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.
Z-0387-2019
Product summary
- Event
- Event 81181
- Status
- Terminated
- Classification
- Class II
- Quantity
- 566,737 total
- Official record key
device-enforcement:Z-0387-2019
Official wording
Reason: The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.
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.
Derived failure modes
-
Unknown
The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.