Recall Z-2671-2020— Becton Dickinson & Company
Class II · Terminated
Class II FDA medical device recall by Becton Dickinson & Company, initiated 2020-06-19, terminated 2022-07-29. It names one FDA 510(k) clearance: K153440. Product: SafeStep Huber Needle Set; Catalog Numbers LH-0029 (UDI 00801741066160), LH-0030 (UDI 00801741066184), LH-0031 (UDI 00801741066207), LH-0032 (UDI 00801741066221), LH-0033 (UDI 00801741066245), LH-0034 (UDI 00801741066269), LH-0035 (UDI 00801741066283), LH-0036 (UDI 00801741066306), LH-0037 (UDI 00801741066320), LH-0038 (UDI 00801741066344), LH-0039 (UDI 00801741066368), LH-0040 (UDI 00801741066382). 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..
- Recalling firm
- Becton Dickinson & Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-19
- Terminated
- 2022-07-29
- Firm location
- Franklin Lakes, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
SafeStep Huber Needle Set; Catalog Numbers LH-0029 (UDI 00801741066160), LH-0030 (UDI 00801741066184), LH-0031 (UDI 00801741066207), LH-0032 (UDI 00801741066221), LH-0033 (UDI 00801741066245), LH-0034 (UDI 00801741066269), LH-0035 (UDI 00801741066283), LH-0036 (UDI 00801741066306), LH-0037 (UDI 00801741066320), LH-0038 (UDI 00801741066344), LH-0039 (UDI 00801741066368), LH-0040 (UDI 00801741066382)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.