Intravascular (IV) Administration Sets
Medical device recall Z-0446-2016. Published in FDA’s Enforcement Report on Dec 23, 2015.
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 Dec 23, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 147,350 units 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?
Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization (clearance) of the devices.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK2394, MK2508, MK2227
147,350 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
59963616 59963616 59963616 59963616 59963616 59963616 59963616 59963616 59963616 59963616 60062124 59736951 59682161 59682161 59727259 59727259 59727259 59391951 59391951 59391951 59391951 59391951 59407670 59407670 59407670 59407670…
Every code shown here, 1,998 characters
59963616 59963616 59963616 59963616 59963616 59963616 59963616 59963616 59963616 59963616 60062124 59736951 59682161 59682161 59727259 59727259 59727259 59391951 59391951 59391951 59391951 59391951 59407670 59407670 59407670 59407670 59407670 59407670 59407670 59464977 59464977 59464977 59464977 59464977 59464977 59474664 59474664 59474664 59474664 59481176 59481176 59523673 59523673 59523673 59523673 59523673 59540977 59540977 59540977 59540977 59540977 59566031 59566031 59566031 59566031 59566031 59579648 59579648 59579648 59579648 59612801 59612801 59612801 59612801 59612801 59642070 59642070 59642070 59642070 59642070 59752540 59752540 59752540 59752540 59752541 59752541 59752541 59752541 59752541 59752541 59752542 59752542 59752542 59752542 59752542 59766776 59766776 59766776 59766776 59800860 59800860 59800860 59800860 59853819 59853819 59853819 59853819 59876072 59876072 59876072 59876072 59876072 59918517 59918517 59918517 59918517 59923159 59923159 59923159 59923159 59976190 59976190 59976190 59976190 60001498 60001498 60001498 60001498 60001498 60036774 60036774 60036774 60036774 60067981 60067981 60067981 60067981 60090227 60090227 60090227 60090227 60130963 60169135 59631618 59631618 59631618 59736950 59736950 59893256 60036659 60101804 59352290 59352290 59401653 59960651 60008913 59434482 59434482 59474616 59474616 59474616 59474616 59474616 59474616 59474616 59881664 59960651 60008913 60062203 59677539 59684790 59684790 59684790 59976047 60036659 60008913 59677539 59684790 59684790 59684790 59421416 59352290 59352290 59371805 59401653 59401653 59434482 59434482 59434482 59501176 59501176 59645776 59682161 59682161 59762126 59783966 59804551 59815561 59881664 59960651 59960651 60008913 60008913 60062203 60154456 59380744 59352290 59371805 59371805 59501176 59804551 60008913 60154456 59430382 59430382 59684790 59684790 59352290 59352290 59352290 59352290 59352290 59352290 59352290 59352290 59352290 59371805 59371805 59371805 59371805 59371805 59371805…
FDA’s list runs to 15,560 characters. The first part is shown; the rest is on FDA’s record.
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.
US
These words name no state.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Nov 13, 2015.
- FDA classified it on Dec 17, 2015.
- FDA’s Enforcement Report published it on Dec 23, 2015.
- FDA terminated it on Jul 15, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Edwards Lifesciences, LLC, of Irvine, CA.
- 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.”
- FDA’s list of codes runs to 15,560 characters; the first part is shown here, and the rest is on FDA’s record.
- 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.