FDA (Devices) recall action 85853

Becton Dickinson & Company recalled 12 products on 2020-07-29

The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.

Products: 12
Announced: 2020-07-29
Critical: 0
Units: 63,553,584

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–12 of 12

HighFDA (Devices)··2020-07-29
Becton Dickinson Recalls PowerLoc MAX Infusion Sets Due to Tubing Cracks
Becton Dickinson is recalling PowerLoc MAX Power Injectable Infusion Sets because tubing may crack or break near the Luer or Y site, risking leakage of chemicals or blood.
Product
PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 00801741047329), 0131915 (UDI 00801741047336), 0131975 (UDI 00801741047343), 0132010 (UDI 00801741047350), 0132015 (UDI 00801741047367), 0132075 (UDI 00801741047374), 0132210 (UDI 00801741047381), 0132215
Category
Distribution
0 states
SevereFDA (Devices)··2020-07-29
Becton Dickinson SafeStep Huber Needle Set Recall for Tubing Cracks
Becton Dickinson is recalling SafeStep Huber Needle Sets with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kits due to potential tubing cracks that may cause leakage.
Product
SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers PA-0031G (UDI 00801741085666), PA-0031YNG (UDI 00801741085673), PA-0032G (UDI 00801741087639), PA-0033G (UDI 00801741096433)
Category
Distribution
0 states
HighFDA (Devices)··2020-07-29
Becton Dickinson Recalls SafeStep Huber Needle Sets Due to Tubing Cracks
Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack or break, potentially causing leakage of chemicals or biohazard materials.
Product
SafeStep Huber Needle Set; 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 0080174106630
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Distribution
0 states
HighFDA (Devices)··2020-07-29
Becton Dickinson Recalls PowerLoc MAX Infusion Port Access Kits
Becton Dickinson is recalling PowerLoc MAX Power Injectable Infusion Port Access Kits due to potential tubing cracks that may cause leakage of hazardous materials.
Product
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)
Category
Distribution
0 states
SevereFDA (Devices)··2020-07-29
Becton Dickinson Recalls PowerLoc MAX Infusion Sets Due to Tubing Cracks
Becton Dickinson is recalling PowerLoc MAX infusion sets because tubing cracks may cause leakage of chemicals or biohazard materials.
Product
PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Catalog Numbers AN132075 (UDI 00801741118968), AN142010 (UDI 00801741119231), AN142010G (UDI 00801741119323), AN142075 (UDI 00801741119224)
Category
Distribution
0 states
SevereFDA (Devices)··2020-07-29
Becton Dickinson Recalls SafeStep Huber Needle Sets Due to Tubing Cracks
Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack, risking chemical exposure, blood loss, or infection.
Product
SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog Number CPA00040 (UDI 00801741143892)
Category
Distribution
0 states
SevereFDA (Devices)··2020-07-29
Becton Dickinson Recalls SafeStep Huber Needle Sets Due to Tubing Cracks
Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack or break, risking leakage of chemicals or blood.
Product
SafeStep Huber Needle Set AllPoints Port Access System; Catalog Numbers AN152075 (UDI 00801741119484), AN152075G (UDI 00801741119583), AN162010 (UDI 00801741119682), AN162010G (UDI 00801741119446), AN162075 (UDI 00801741119675), AN162075G (UDI 00801741119439)
Category
Distribution
0 states
HighFDA (Devices)··2020-07-29
Becton Dickinson Recalls SafeStep Huber Needle Sets Due to Tubing Cracks
Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack or break, potentially causing leakage of hazardous chemicals or blood.
Product
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 008
Category
Distribution
0 states
SevereFDA (Devices)··2020-07-29
Becton Dickinson Recalls PowerLoc MAX Infusion Sets Due to Tubing Cracks
Becton Dickinson is recalling PowerLoc MAX infusion sets because tubing may crack, risking leakage of chemicals or biohazard materials.
Product
PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers 2132010G (UDI 00801741095504), 2132015G (UDI 00801741095511), 2141910G (UDI 00801741095542), 2142010G (UDI 00801741085680), 2142015G (UDI 00801741085680), 2
Category
Distribution
0 states
HighFDA (Devices)··2020-07-29
Becton Dickinson Recalls SafeStep Huber Needle Set Port Access Kits
Becton Dickinson is recalling SafeStep Huber Needle Set Port Access Kits because tubing may crack or break, potentially causing leakage of hazardous materials or blood.
Product
SafeStep Huber Needle Set Port Access Kit; 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-00
Category
Distribution
0 states
HighFDA (Devices)··2020-07-29
Becton Dickinson Recalls PowerLoc MAX Infusion Sets Due to Tubing Cracks
Becton Dickinson is recalling PowerLoc MAX infusion sets because tubing may crack, risking chemical exposure, blood loss, or infection.
Product
PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Numbers CPA00001 (UDI 00801741098345), CPA00002 (UDI 00801741098352), CPA00028 (UDI 00801741129728), CPA00032 (UDI 00801741137501), CPA00033 (UDI 00801741137501), CPA00036 (UDI 00801741138911), CPA00051 (U
Category
Distribution
0 states
SevereFDA (Devices)··2020-07-29
Becton Dickinson Recalls SafeStep Huber Needle Sets Due to Tubing Cracks
Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack, risking leakage of chemicals or blood.
Product
SafeStep Huber Needle Set myPICK Port Access Kit; Catalog Numbers CPA00020A (UDI 00801741129827), CPA00042A (UDI 00801741182969), CPA00049 (UDI 00801741175695)
Category
Distribution
0 states