FDA Medical Device Recalls (openFDA)
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 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.
- Recall number
- Z-0387-2019
- Recalling firm
- Becton Dickinson & Company
- 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.
- Status
- Terminated
- Initiated
- 2018-09-26
- Posted
- not on file
- Terminated
- 2020-04-13
- 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 Arab Emirates and Saudi Arabia.
- Lot, serial or model codes
- Batch numbers: 16127933 17017602 17055977 17117153 17125385 18015788
- 510(k) numbers
- ["K811885"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28