—#167702

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.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K811885
Affected lot / code info: Batch numbers: 16127933 17017602 17055977 17117153 17125385 18015788

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

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.

Timeline

Recall initiated: 2018-09-26
Terminated: 2020-04-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167702. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.