FDA Device recall Z-2666-2020
SafeStep Huber Needle Set Port Access Kit
- FDA Device
- Class II
- terminated
- Published 2020-07-29
On 2020-07-29 the FDA classified a Class II recall of SafeStep Huber Needle Set Port Access Kit by Becton Dickinson And, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2666-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-19 |
| Published | 2020-07-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Becton Dickinson And |
| Distribution | n/a |
Product
SafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801741085482), PA-0029YN (UDI 00801741085499), PA-0030 (UDI 00801741085505), PA-0030YN (UDI 00801741085512), PA-0031 (UDI 00801741085529), PA-0031YN (UDI 00801741085536), PA-0032 (UDI 00801741085543), PA-0032YN (UDI 00801741085550), PA-0033 (UDI 00801741085567), PA-0033YN (UDI 00801741085574), PA-0034 (UDI 00801741085581), PA-0034YN (UDI 00801741085598), PA-0036 (UDI 00801741085604), PA-0038 (UDI 00801741085628), PA-0038YN (UDI 00801741085635)
Reason
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.
Identifiers
| code_info | Catalog Numbers PA-0029 (UDI 00801741085482), PA-0029YN (UDI 00801741085499), PA-0030 (UDI 00801741085505), PA-0030YN (…Catalog Numbers PA-0029 (UDI 00801741085482), PA-0029YN (UDI 00801741085499), PA-0030 (UDI 00801741085505), PA-0030YN (UDI 00801741085512), PA-0031 (UDI 00801741085529), PA-0031YN (UDI 00801741085536), PA-0032 (UDI 00801741085543), PA-0032YN (UDI 00801741085550), PA-0033 (UDI 00801741085567), PA-0033YN (UDI 00801741085574), PA-0034 (UDI 00801741085581), PA-0034YN (UDI 00801741085598), PA-0036 (UDI 00801741085604), PA-0038 (UDI 00801741085628), PA-0038YN (UDI 00801741085635). Lot Numbers: REDX2834 REDX4856 REDY1792 REDY2773 REEN2075 REEN4559 REEP1004 REEP3058 REEQ4021 REER0466 REER1235 REER2399 REDW3688 REDZ3026 REEN1109 REEP2916 REEQ2690 REEQ4063 REDS1399 REDS1875 REDS3371 REDS4425 REDT1836 REDU4512 REDX2861 REDY0778 REDY3542 REDZ3102 REEN1044 REEP3066 REEQ2648 REER2400 REDR1897 REDR2695 REDR2796 REDS1288 REDS1400 REDS2408 REDS4621 REDT0697 REDT1645 REDT1837 REDT2924 REDT4207 REDU2262 REDU2347 REDU3328 REDV1094 REDV1239 REDV2772 RED |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2666-2020%22
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