REF 7617408D — Class II medical device recall Z-1655-2021
Terminated recall by Bard Access Systems Inc., reported 2021-05-26, distributed nationwide. Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inabil
| Recall number | Z-1655-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Access Systems Inc., Salt Lake City, UT, United States |
| Recall initiated | 2021-04-07 |
| Classified | 2021-05-20 |
| Reported by FDA | 2021-05-26 |
| Terminated | 2023-06-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BD, BE, BR, CA, CL, CN, HK, IN, JP, KR, MY, SG, TH, TW |
| UPC / GTIN / UDI-DI | 10801741035262 |
| Lot numbers | REDX1464, REEN4697, REEP0632, REEV2091, REEW3144, REEX1265 |
| Model numbers | 7617408D |
Product
REF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035262 - Product Usage: is designed for use when central venous catheterization is prescribed.
Reason for recall
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
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-1655-2021. 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.