Reported Jul 29, 2020 · Terminated
PowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 2131910 (UDI 00801741044151), 2131915 (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?
- PowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 2131910 (UDI 00801741044151), 2131915 (UDI 00801741044168), 2131975 (UDI 00801741044175), 2132010 (UDI 00801741044151), 2132015 (UDI 00801741044199), 2132075 (UDI 00801741044205), 2132210 (UDI 00801741044212), 2132275 (UDI 00801741044236), 2141910 (UDI 00801741044243), 2141915 (UDI 00801741044250), 2141975 (UDI 00801741044267), 2142010 (UDI 00801741044274), 2142015 (UDI 00801741044281), 2142075 (UDI 00801741044298), 2142210 (UDI 00801741044304), 2142215 (UDI 00801741044311), 2142275 (UDI 00801741044328)
- Lot codes and dates
Catalog Numbers 2131910 (UDI 00801741044151)2131915 (UDI 00801741044168)2131975 (UDI 00801741044175)2132010 (UDI 00801741044151)2132015 (UDI 00801741044199)2132075 (UDI 00801741044205)2132210 (UDI 00801741044212)2132275 (UDI 00801741044236)2141910 (UDI 00801741044243)2141915 (UDI 00801741044250)2141975 (UDI 00801741044267)2142010 (UDI 00801741044274)2142015 (UDI 00801741044281)2142075 (UDI 00801741044298)2142210 (UDI 00801741044304)2142215 (UDI 00801741044311)2142275 (UDI 00801741044328)
- Lot Numbers
120 of 120 codes
REDW3798REDY2866REDZ1719REEN3137REEP0951REEQ2684REEQ4092REER1229REEQ0664REEQ1649REER0459REDZ1818REEP3049REDW1092REDX3754REDY1682REDY2971REDY3530REDZ1070REEN3271REEN4480REEP0992REEP3957REEQ1647REEQ2724REEQ4093REER1266REDY3719REEN1270REEP0952REEQ0684REEQ2676REEQ4054REER0460REDT2879REDU2256REDU3371REDU4487REDV1088REDV2972REDV3470REDW0402REDW1087REDX1518REDY1804REDY2867REDY3531REDZ1069REEN1104REEN4481REEP0953REEP3958REEQ0665REEQ1650REER0530REEN2139REEP4053REER0461REDY3720REEQ4094
- 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.
Want the full recall guide?
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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