PCEA ASV Yellow Microbore
Medical device recall Z-0386-2019. Published in FDA’s Enforcement Report on Nov 14, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 14, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 38 states named
- 566,737 total how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
566,737 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,121 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
38 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Florida
- Georgia
- Guam
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Maryland
- Maine
- Michigan
- Missouri
- Montana
- North Carolina
- Nebraska
- New Jersey
- Nevada
- New York
- Ohio
- Oregon
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 26, 2018.
- FDA classified it on Nov 3, 2018.
- FDA’s Enforcement Report published it on Nov 14, 2018.
- FDA terminated it on Apr 13, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Becton Dickinson & Company, of Franklin Lakes, NJ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.