HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for… — Class II medical device recall Z-2818-2018
Terminated recall by Arrow International Inc, reported 2018-08-22, distributed nationwide. The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product
| Recall number | Z-2818-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2018-07-10 |
| Classified | 2018-08-14 |
| Reported by FDA | 2018-08-22 |
| Terminated | 2020-05-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, DE, FI, GB, HU, NL, ZA |
| Quantity | 7,024 units |
| Reason classes | sterility |
Product
HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous sheath introducer.
Reason for recall
The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.
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-2818-2018. 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.