FDA Device recall Z-1965-2013
Arrow International, Inc
- FDA Device
- Class II
- terminated
- Published 2013-08-21
On 2013-08-21 the FDA classified a Class II recall of Arrow International, Inc by Arrow International, citing 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 ide….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1965-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-31 |
| Published | 2013-08-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Arrow International |
| Distribution | AL, AZ, CT, IL, KS, NC, NJ, PA, RI, VA |
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
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.
Identifiers
| code_info | Catalog # AK-17702-CDC, lot # RF2083258 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1965-2013%22
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