Arrow Transradial Artery Access products Arrow Transradial Artery… — Class II medical device recall Z-0468-2014
Terminated recall by Arrow International Inc, reported 2013-12-18, distributed nationwide. There is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which
| Recall number | Z-0468-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2013-10-09 |
| Classified | 2013-12-09 |
| Reported by FDA | 2013-12-18 |
| Terminated | 2015-08-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CN, IE, NZ, SG, TH |
| Quantity | 294,430 |
| Lot numbers | 2013-09, 2013-10, 2013-11, 2013-12, 2014-01, 2014-02, 2014-04, 2014-05, 2014-06, 2014-07, 2014-08, 2014-09, 2014-10, 2014-11, 2015-01, 2015-02, 2015-03, 2015-04, 2015-05, 2015-06, 2015-08, 2015-09, 2015-10, 2015-11, 2015-12, 2016-01, 2016-02, 2016-03, 2016-04, 2016-05, 2016-06, 2016-07, 2016-08, 2016-09, 2016-10, 2016-11, 2016-12, 2017-01, 2017-02, 2017-03 and 221 more |
| Model numbers | 2013-09, 2013-10, 2013-11, 2013-12, 2014-01, 2014-02, 2014-04, 2014-05, 2014-06, 2014-07, 2014-08, 2014-09, 2014-10, 2014-11, 2015-01, 2015-02, 2015-03, 2015-04, 2015-05, 2015-06, 2015-08, 2015-09, 2015-10, 2015-11, 2015-12 and 236 more |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0468-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.