Class 2 Device Recall PCEA ASV Yellow Microbore

• Date Initiated by Firm: September 26, 2018
• Create Date: November 04, 2018
• Recall Status: Terminated on April 13, 2020
• Recall Number: Z-0386-2019
• Recall Event ID: 81181
• 510(K)Number: K811885
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07; ; 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.
• Code Information: Batch numbers: 15086977 15095397 15095915 15096391 15096849 15096850 15106576 15106951 15115143 15115716 15115717 16017458 16025336 16025977 16036016 16045460 16045487 16055501 16065137 16065138 16065714 16066549 16067125 16067126 16067127 16067128 16077716 16085262 16085367 15026445 15026291 15026195 15026194 15025581 14116628 14115971 14106583 14106255 14105065 16085368 16087180 16095824 16095862 16096932 16096933 16105618 16107358 16107359 16115132 16125018 16126788 16127223 17015091 17016118 17016119 17017235 17025472 17026261 17026967 17036238 17036239 17056659 17057076 17057077 17065203 17065204 17065249 17066157 15016971 15016044 15015678 14125371 14116627 14056317 14045325 14036825 14036236 14035806 14096716 14096388 14095389 14086964 14085752 14085232 14077092 14076307 14075202 14066846 14066080 14035268 14026691 14026388 14025707 14016290 14016373 14015841 13125080 13116634 13115751 13115436 17085229 17085260 17087278 17096726 17096817 17096818 17096980 17116510 17117476 17117526 17125486 17125487 17125488 17125559 17126893 17126907 18015151 18015152 18015153 18016346 18026103 18026223 18026224
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: BD Support Center; 888-562-6018
• Manufacturer Reason for Recall: The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.
• FDA Determined 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 in Commerce: 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 Arab Emirates and Saudi Arabia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FPA and Original Applicant = Y