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U.S. Department of Health and Human Services

Class 2 Device Recall PCEA Kit ASV Yellow Stripe Microbore

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  Class 2 Device Recall PCEA Kit ASV Yellow Stripe Microbore see related information
Date Initiated by Firm September 26, 2018
Create Date November 04, 2018
Recall Status1 Terminated 3 on April 13, 2020
Recall Number Z-0387-2019
Recall Event ID 81181
510(K)Number K811885  
Product Classification Set, administration, intravascular - Product Code FPA
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.
Code Information Batch numbers: 16127933 17017602 17055977 17117153 17125385 18015788 
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 2		 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
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