Reported Jul 29, 2020 · Terminated
SafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801741085482), PA-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 Port Access KitCatalog 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 codes and dates
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
136 of 136 codes
REDX2834REDX4856REDY1792REDY2773REEN2075REEN4559REEP1004REEP3058REEQ4021REER0466REER1235REER2399REDW3688REDZ3026REEN1109REEP2916REEQ2690REEQ4063REDS1399REDS1875REDS3371REDS4425REDT1836REDU4512REDX2861REDY0778REDY3542REDZ3102REEN1044REEP3066REEQ2648REER2400REDR1897REDR2695REDR2796REDS1288REDS1400REDS2408REDS4621REDT0697REDT1645REDT1837REDT2924REDT4207REDU2262REDU2347REDU3328REDV1094REDV1239REDV2772REDV2983REDW0413REDX3752REDY1723REDY3731REDZ0146REDZ1859REDZ3027REEN2076REEN2144
- 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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