Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central… — Class II medical device recall Z-1633-2014
Terminated recall by Arrow International Inc, reported 2014-05-28. The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW
| Recall number | Z-1633-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2013-07-17 |
| Classified | 2014-05-19 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2015-03-30 |
| Quantity | 4,285 |
| Reason classes | labeling |
| Model numbers | ASK-45703-PHF |
Product
Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF.
Reason for recall
The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe; however, the kit contains, and should state, Introducer Needle: 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe. As a result of this labeling inconsistency, if the clinician were to place the needle under x-r
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-1633-2014. 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.