REF: 386862 — Class II medical device recall Z-0025-2024
Ongoing recall by Becton Dickinson Infusion Therapy Systems Inc., reported 2023-10-11, distributed nationwide. There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull thr
| Recall number | Z-0025-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson Infusion Therapy Systems Inc., Sandy, UT, United States |
| Recall initiated | 2023-08-29 |
| Classified | 2023-10-03 |
| Reported by FDA | 2023-10-11 |
| Distributed | Nationwide (US) |
| Quantity | 98,000 units |
| UPC / GTIN / UDI-DI | 00382903868629 |
| Lot numbers | 2238464 |
| Model numbers | 386862 |
Product
REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
Reason for recall
There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull through the safety shield and disconnect from the needle safety shield leaving the contaminated needle point exposed.
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-0025-2024. 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.