FDA Device recall Z-1713-2014
Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduc…
- FDA Device
- Class II
- terminated
- Published 2014-06-11
On 2014-06-11 the FDA classified a Class II recall of Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduc… by Arrow International, citing arrow is recalling the Arrow¿ Percutaneous Sheath Introducer Kits due to dilator tip damage noted during internal inspection. Dilator tip damage has the potential to result in ves….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1713-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-14 |
| Published | 2014-06-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Arrow International |
| Distribution | US |
Product
Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
Reason
Arrow is recalling the Arrow¿ Percutaneous Sheath Introducer Kits due to dilator tip damage noted during internal inspection. Dilator tip damage has the potential to result in vessel damage.
Identifiers
| code_info | Product codes and lot numbers: AK-09903-A 23F13G0162 AK-09903-S RF3064511 CDC-09903-1A 23F13G0642 AK-09903-J 23F13G040…Product codes and lot numbers: AK-09903-A 23F13G0162 AK-09903-S RF3064511 CDC-09903-1A 23F13G0642 AK-09903-J 23F13G0400 ASK-09903-CMC RF3064673 NL-09903-S 23F13G0630 AK-09903-LFSP RF3065449 ASK-09903-CMC 23F13G0343 NR-09903-S 23F13G0180 AK-09903-S 23F13G0204 ASK-09903-NKC 23F13G0336 SI-09903-E RF3064710 AK-09903-S RF3064956 ASK-09903-TJ 23F13G0567 SI-09903-E RF3064915 AK-09903-S 23F13H0195 CDC-09903-1A RF3065316 |
|---|
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-1713-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.