CLASS II Device recall · Reported 29 Jul 2020 · FDA Enforcement Report

PowerLoc MAX Power Injectable Infusion Port Access Kit recalled

Becton Dickinson & is recalling PowerLoc MAX Power Injectable Infusion Port Access Kit. The recall was initiated on 19 Jun 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog 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: REDW3798 REDY2866 REDZ1719 REEN3137 REEP0951 REEQ2684 REEQ4092 REER1229 REEQ0664 REEQ1649 REER0459 REDZ1818 REEP3049 REDW1092 REDX3754 REDY1682 REDY2971 REDY3530 REDZ1070 REEN3271 REEN4480 REEP0992 REEP3957 REEQ1647 REEQ2724 REEQ4093 REER1266 REDY3719 REEN1270 REEP0952 REEQ0684 REEQ2676 REEQ4054 REER0460 REDT2879 REDU2256 REDU3371 REDU4487 REDV1088 REDV2972 REDV3470 REDW0402 REDW1087 REDX1518 REDY1804 REDY2867 REDY3531 REDZ1069 REEN1104 REEN4481 REEP0953 REEP3958 REEQ0665 REEQ1650 REER0530 REEN2139 REEP4053 REER0461 REDY3720 REEQ4094 REDW3682 REDY0827 REDZ1071 REEP0994 REER0539 REEN4551 REEP0954 REEQ1648 REDW1197 REDY2972 REDZ3130 REEP0995 REEP2909 REDW0546 REDX1519 REDX4930 REDY1683 REDY2868 REDY3532 REDZ1064 REDZ1819 REEN1046 REEN2146 REEP0955 REEP3052 REEP3959 REER0462 REDZ1721 REEQ2678 REDV1236 REDW0407 REDW0550 REDX4852 REDY0773 REDY0828 REDY1684 REDY2973 REDZ1063 REDZ1072 REDZ1820 REEN1271 REEN3273 REEP0956 REEP0996 REEP1728 REEP3053 REEP4054 REEQ1664 REEQ2720 REER0540 REDW3683 REDY3721 REEN4552 REER1261 REEN3155 REDW0403 REDY1685 REDZ1722 REEP0997 REEQ0666

Quantity recalled5,296,132 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2662-2020
FDA event ID: 85853
Recalling firm: Becton Dickinson &, Franklin Lakes, NJ
Classification: Class II
Status: Terminated
Recall initiated: 19 Jun 2020
FDA classified: 18 Jul 2020
Reported: 29 Jul 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

19 Jun 2020	Recall initiated by company
18 Jul 2020	Classified by FDA	+29 days
29 Jul 2020	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

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)

Where it was distributed

Worldwide Distribution

Questions about this recall

Is PowerLoc MAX Power Injectable Infusion Port Access Kit recalled?

Yes. Becton Dickinson & recalled PowerLoc MAX Power Injectable Infusion Port Access Kit on 19 Jun 2020. The recall is Class II and its status is Terminated. Recall number Z-2662-2020.

Why was it recalled?

Which lots are affected?

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: REDW3798 REDY2866 REDZ1719 REEN3137 REEP0951 REEQ2684 REEQ4092 REER1229 REEQ0664 REEQ1649 REER0459 REDZ1818 REEP3049 REDW1092 REDX3754 REDY1682 REDY2971 REDY3530 REDZ1070 REEN3271 REEN4480 REEP0992 REEP3957 REEQ1647 REEQ2724 REEQ4093 REER1266 REDY3719 REEN1270 REEP0952 REEQ0684 REEQ2676 REEQ4054 REER0460 REDT2879 REDU2256 REDU3371 REDU4487 REDV1088 REDV2972 REDV3470 REDW0402 REDW1087 REDX1518 REDY1804 REDY2867 REDY3531 REDZ1069 REEN1104 REEN4481 REEP0953 REEP3958 REEQ0665 REEQ1650 REER0530 REEN2139 REEP4053 REER0461 REDY3720 REEQ4094 REDW3682 REDY0827 REDZ1071 REEP0994 REER0539 REEN4551 REEP0954 REEQ1648 REDW1197 REDY2972 REDZ3130 REEP0995 REEP2909 REDW0546 REDX1519 REDX4930 REDY1683 REDY2868 REDY3532 REDZ1064 REDZ1819 REEN1046 REEN2146 REEP0955 REEP3052 REEP3959 REER0462 REDZ1721 REEQ2678 REDV1236 REDW0407 REDW0550 REDX4852 REDY0773 REDY0828 REDY1684 REDY2973 REDZ1063 REDZ1072 REDZ1820 REEN1271 REEN3273 REEP0956 REEP0996 REEP1728 REEP3053 REEP4054 REEQ1664 REEQ2720 REER0540 REDW3683 REDY3721 REEN4552 REER1261 REEN3155 REDW0403 REDY1685 REDZ1722 REEP0997 REEQ0666

Where was it sold?

Worldwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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