Reported Jul 29, 2020 · Terminated
SafeStep Huber Needle Set with Y Injection Site and Medegen Needleless Injection Cap; Catalog Numbers LH-0029YN (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 Set with Y Injection Site and Medegen Needleless Injection Cap; Catalog Numbers LH-0029YN (UDI 00801741066177), LH-0030YN (UDI 00801741066191), LH-0031YN (UDI 00801741066214), LH-0032YN (UDI 00801741066238), LH-0033YN (UDI 00801741066252), LH-0034YN (UDI 00801741066276), LH-0035YN (UDI 00801741066290 ), LH-0036YN (UDI 00801741066313), LH-0037YN (UDI 00801741066337), LH-0038YN (UDI 00801741066351), LH-0039YN (UDI 00801741066313), LH-0040YN (UDI 00801741066399)
- Lot codes and dates
- Catalog Numbers LH-0029YN (UDI 00801741066177), LH-0030YN (UDI 00801741066191), LH-0031YN (UDI 00801741066214), LH-0032YN (UDI 00801741066238), LH-0033YN (UDI 00801741066252), LH-0034YN (UDI 00801741066276), LH-0035YN (UDI 00801741066290 ), LH-0036YN (UDI 00801741066313), LH-0037YN (UDI 00801741066337), LH-0038YN (UDI 00801741066351), LH-0039YN (UDI 00801741066313), LH-0040YN (UDI 00801741066399)
- Lot Numbers
146 of 146 codes
ASDQF068ASDRF001ASDRF002ASDRF003ASDRF005ASEPF018ASEPF019ASEPF020ASEPF026ASEQF008ASEQF025ASEQF030ASEQF039ASEQF041ASCYF038ASCYF097ASDQF065ASDQF066ASDQF067ASDWF061ASDWF062ASDWF063ASDWF064ASDWF065ASEQF045ASEQF046ASCYF039ASCYF065ASCYF093ASCZF007ASCZF008ASCZF018ASCZF019ASCZF041ASCZF042ASDNF026ASDQF027ASDQF029ASDQF037ASDQF043ASDQF051ASDQF061ASDRF037ASDYF011ASDYF016ASDYF024ASDYF034ASDYF045ASDYF055ASDYF064ASDYF066ASDYF075ASDYF078ASDYF087ASDZF073ASDZF077ASDZF087ASDZF094ASENF004ASENF009
- ASEQF104 Additional Lot as of 9/11/20ASEQF034
- 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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