Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath… — Class II medical device recall Z-1713-2014
Terminated recall by Arrow International Inc, reported 2014-06-11, distributed nationwide. Arrow is recalling the Arrow¿ Percutaneous Sheath Introducer Kits due to dilator tip damage noted during inter
| Recall number | Z-1713-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2014-04-14 |
| Classified | 2014-06-04 |
| Reported by FDA | 2014-06-11 |
| Terminated | 2016-10-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 15,424 |
| Lot numbers | 23F13G0162, 23F13G0180, 23F13G0204, 23F13G0336, 23F13G0343, 23F13G0400, 23F13G0567, 23F13G0630, 23F13G0642, 23F13H0195, AK-09903-A, AK-09903-J, AK-09903-LFSP, AK-09903-S, ASK-09903-CMC, ASK-09903-NKC, ASK-09903-TJ, CDC-09903-1A, NL-09903-S, NR-09903-S, RF3064511, RF3064673, RF3064710, RF3064915, RF3064956, RF3065316, RF3065449, SI-09903-E |
Product
Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
Reason for recall
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.
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-1713-2014. 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.