Arrow International — Class II medical device recall Z-1965-2013
Terminated recall by Arrow International Inc, reported 2013-08-21, distributed in AL, AZ, CT, IL, KS, NC, NJ, PA…. Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit con
| Recall number | Z-1965-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2013-07-31 |
| Classified | 2013-08-14 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2015-04-28 |
| Distributed | AL, AZ, CT, IL, KS, NC, NJ, PA, RI, VA |
| Quantity | 156 |
| Reason classes | labeling |
| Lot numbers | RF2083258 |
| Model numbers | AK-17702-CDC |
Product
Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.
Reason for recall
Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen.
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-1965-2013. 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.