FDA Device recall Z-2489-2015
Arrow International, Inc
- FDA Device
- Class II
- terminated
- Published 2015-09-09
On 2015-09-09 the FDA classified a Class II recall of Arrow International, Inc by Arrow International, citing saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. No injuries reported.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2489-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-30 |
| Published | 2015-09-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Arrow International |
| Distribution | US |
Product
Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days
Reason
saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. No injuries reported.
Identifiers
| code_info | Material Nos.: ASK-04001-DU4 ASK-04001-DU5 ASK-04001-DU6 ASK-04001-DU6 ASK-04001-DU7 ASK-04001-DU8 ASK-35052-JH…Material Nos.: ASK-04001-DU4 ASK-04001-DU5 ASK-04001-DU6 ASK-04001-DU6 ASK-04001-DU7 ASK-04001-DU8 ASK-35052-JHVA1 ASK-45041-JHVA CDC-44041-VPS CDC-35063-VPS CDC-35541-VPS CDC-35552-VPS CDC-35563-VPS CDC-44041-VPS CDC-45541-VPS VPS7220B CDC-34041-VPS CDC-34052-VPS CDC-34063-VPS CDC-35041-VPS CDC-35041-VPS CDC-35052-VPS CDC-35063-VPS ASK-04001-DU5 CDC-45041-VPS ASK-04001-UOC ASK-35041-JHVA ASK-35052-JHVA CDC-34041-VPS VPS7220B VPS7220B VPS7220B VPS7220B Batch Nos.: 23F14A1779 23F14D0281 23F14M0072 23F14D1271 23F14G0101 23F14G1295 23F14E1325 23F15A1407 23F14F0406 23F15B1012 23F14J0973 23F14G0091 23F15B1630 23F14F0782 RF3053214 23F14M0791 23F14K1260 RF3052236 23F14J1421 23F13M0751 23F13L0144 23F14L0635 RF3052644 23F14K1255 23F14D0332 23F14B1160 23F15B1628 RF3064510 23F14M0026 23F14G0107 23F14D0759 RF3042008 23F14A0375 23F14A1189 23F14J1433 23F14F1092 23F13M0589 23F14A1493 23F14B1128 23F15A0122 23F14G0916 23F14A |
|---|
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-2489-2015%22
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