Reported Jul 29, 2020 · Terminated
SafeStep Huber Needle Set; Catalog Numbers LH-0029 (UDI 00801741066160), LH-0030 (UDI 00801741066184), LH-0031 (UDI…
Becton Dickinson & Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Becton Dickinson & Company · 1 Becton Dr · Franklin Lakes, NJ · 07417-1815
Is this the product you have?
SafeStep Huber Needle SetCatalog 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)
- Lot codes and dates
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)
- Lot Numbers
269 of 269 codes
ASCYF001ASCYF017ASDRF018ASDRF031ASDRF040ASDSF065ASDSF070ASDTF004ASDTF007ASDVF048ASDVF054ASDXF058ASDXF060ASDXF066ASDYF071ASDYF077ASDYF098ASDZF010ASDZF017ASDZF024ASDZF035ASDZF036ASDZF046ASDZF071ASDZF081ASDZF093ASENF002ASERF025ASERF032ASCYF015ASCYF016ASCZF027ASDRF043ASDRF044ASDRF054ASDRF055ASDRF056ASDVF058ASDVF063ASDXF020ASDXF045ASENF011ASENF014ASERF004ASCYF089ASCYF090ASCYF091ASCYF092ASCZF009ASCZF010ASCZF011ASCZF022ASCZF023ASCZF039ASCZF040ASCZF045ASCZF054ASDPF016ASDQF035ASDQF054
- ASENF057 Additional lot as of 9/11/20ASEQF035
- Amount recalled
- 5,296,132 total
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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