Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous…
Medical device recall Z-0468-2014. Published in FDA’s Enforcement Report on Dec 18, 2013.
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 18, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 294430 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?
There is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event when used on a patient.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.
294430, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Multiple: Expressed as Catalog # (AA#) lot number (RF#), and expiration date (year-month) : AA-15611-S RF0018142 2015-01 AA-15611-S RF1069509 2016-06 AA-15511-S RF0021262 2015-02 AA-15611-S RF1069978 2016-06 AA-15611-S RF0021263 2015-03…
Every code shown here, 1,997 characters
Multiple: Expressed as Catalog # (AA#) lot number (RF#), and expiration date (year-month) : AA-15611-S RF0018142 2015-01 AA-15611-S RF1069509 2016-06 AA-15511-S RF0021262 2015-02 AA-15611-S RF1069978 2016-06 AA-15611-S RF0021263 2015-03 AA-15611-S RF1070556 2016-07 AA-15511-S RF0022395 2015-03, AA-15611-S RF1070730 2016-07, AA-15611-S RF0022652 2015-03, AA-15511-S RF1070880 2016-07, AA-15511-S RF0033719 2015-03, AA-15611-S RF1071062 2016-07, AA-15511-S RF0046459 2015-04, AA-15611-S RF1071206 2016-08, AA-15611-S RF0046461 2015-04, AA-15511-S RF1071354 2016-07, AA-15611-S RF0048269 2015-05, AA-15611-S RF1071757 2016-08, AA-15511-S RF0059652 2015-06, AA-15511-S RF1071798 2016-08, AA-15511-S RF0062416 2015-06, AA-15611-S RF1082042 2016-08, AA-15611-S RF0062419 2015-06, AA-15611-S RF1082374 2016-08, AA-15611-S RF0087575 2015-08, AA-15611-S RF1082709 2016-08, AA-15511-S RF0087577 2015-08, AA-15611-S RF1082956 2016-08, AA-15611-S RF0087845 2015-08, AA-15511-S RF1082959 2016-08, AA-15511-S RF0088503 2015-08, AA-15511-S RF1083632 2016-09, AA-15611-S RF0089041 2015-08, AA-10407-1 RF1093923 2013-09, AA-15511-S RF0091088 2015-09, AA-10507-1 RF1093924 2013-09, AA-15611-S RF0092014 2015-09, AA-10511-1 RF1093925 2013-09, AA-15511-S RF0092144 2015-09, AA-15511-S RF1093936 2016-09, AA-15511-S RF0104465 2015-10, AA-15611-S RF1093937 2016-09, AA-15611-S RF0104466 2015-10, AA-15611-S RF1094515 2016-10, AA-15611-S RF0115587 2015-11, AA-15511-S RF1094910 2016-10, AA-15511-S RF0115903 2015-11, AA-15611-S RF1105690 2016-10, AA-15611-S RF0117454 2015-12, AA-15611-S RF1105980 2016-10, AA-15511-S RF0117682 2015-12, AA-15511-S RF1105983 2016-10, AA-15611-S RF0129193 2016-01, AA-15511-S RF1106517 2016-11, AA-15611-S RF1010343 2016-01, AA-15611-S RF1117682 2016-11, AA-15611-S RF1011171 2016-01, AA-15611-S RF1128383 2016-12, AA-15511-S RF1011172 2016-01, AA-15511-S RF2010359 2017-01, AA-15511-S RF1019756 2016-01, AA-15611-S RF2010467 2017-02, AA-15511-S RF1022056 2016-02, AA-15511-S RF2010675…
FDA’s list runs to 6,115 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.
Worldwide Distribution - USA (Nationwide) and Internationally to Australia, Brazil, Canada, China, Ireland, New Zealand, Singapore, and Thailand.
These words name no state.
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 Oct 9, 2013.
- FDA classified it on Dec 9, 2013.
- FDA’s Enforcement Report published it on Dec 18, 2013.
- FDA terminated it on Aug 12, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Arrow International Inc, of Reading, PA.
- 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 6,115 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
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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.