SafeStep Huber Needle Set AllPoints Port Access System — Class II medical device recall Z-2664-2020
Terminated recall by Becton Dickinson & Company, reported 2020-07-29. Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that ha
| Recall number | Z-2664-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Company, Franklin Lakes, NJ, United States |
| Recall initiated | 2020-06-19 |
| Classified | 2020-07-18 |
| Reported by FDA | 2020-07-29 |
| Terminated | 2022-07-29 |
| Quantity | 5,296,132 total |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 00801741119439, 00801741119446, 00801741119484, 00801741119583, 00801741119675, 00801741119682 |
| Lot numbers | REDR2659, REDR2870, REDS0199, REDS3479, REDS4631, REDS4692, REDT0554, REDT0555, REDT0709, REDT1592, REDT4233, REDU0734, REDU1332, REDU1349, REDU2234, REDU2236, REDU2308, REDU3360, REDU4418, REDV1066, REDV1300, REDV1956, REDV3619, REDV3684, REDW0388, REDW1158, REDW1159, REDW2451, REDW3670, REDX1491, REDX1492, REDX2864, REDX3881, REDX4729, REDX4827, REDY1595, REDY1817, REDY1818, REDY2791, REDY2798 and 32 more |
| Model numbers | AN152075 |
Product
SafeStep Huber Needle Set AllPoints Port Access System; Catalog Numbers AN152075 (UDI 00801741119484), AN152075G (UDI 00801741119583), AN162010 (UDI 00801741119682), AN162010G (UDI 00801741119446), AN162075 (UDI 00801741119675), AN162075G (UDI 00801741119439)
Reason for recall
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
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-2664-2020. 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.