Reported Jul 29, 2020 · Terminated
PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 00801741047329), 0131915 (UDI 00801741047336),…
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 SetCatalog Numbers 0131910 (UDI 00801741047329)0131915 (UDI 00801741047336)0131975 (UDI 00801741047343)0132010 (UDI 00801741047350)0132015 (UDI 00801741047367)0132075 (UDI 00801741047374)0132210 (UDI 00801741047381)0132215 (UDI 00801741047398)0132275 (UDI 00801741047404)0141910 (UDI 00801741047411)0141915 (UDI 00801741047428)0141975 (UDI 00801741047435)0142010 (UDI 00801741047442)0142015 (UDI 00801741047459)0142075 (UDI 00801741047466)0142210 (UDI 00801741047473)0142215 (UDI 00801741047480)0142275 (UDI 00801741047497)
- Lot codes and dates
Catalog Numbers 0131910 (UDI 00801741047329)0131915 (UDI 00801741047336)0131975 (UDI 00801741047343)0132010 (UDI 00801741047350)0132015 (UDI 00801741047367)0132075 (UDI 00801741047374)0132210 (UDI 00801741047381)0132215 (UDI 00801741047398)0132275 (UDI 00801741047404)0141910 (UDI 00801741047411)0141915 (UDI 00801741047428)0141975 (UDI 00801741047435)0142010 (UDI 00801741047442)0142015 (UDI 00801741047459)0142075 (UDI 00801741047466)0142210 (UDI 00801741047473)0142215 (UDI 00801741047480)0142275 (UDI 00801741047497)
- Lot Numbers
211 of 211 codes
ASCXF007ASCXF019ASDRF074ASDRF075ASDRF079ASDRF084ASDVF021ASCXF001ASDNF040ASDNF043ASDVF031ASDWF118ASCXF006ASCXF018ASDRF053ASDRF058ASDRF060ASDRF071ASDVF029ASDWF117ASCYF028ASCYF029ASCZF025ASDPF029ASDQF015ASDQF039ASDQF041ASDRF065ASDTF043ASDTF054ASDTF055ASDTF061ASDVF018ASCYF023ASCYF024ASDTF031ASDTF032ASDTF033ASDTF037ASDTF038ASCYF040ASCYF076ASCZF055ASDNF001ASDNF002ASDNF004ASDNF018ASDQF036ASDTF075ASDTF096ASDTF104ASDTF105ASDTF115ASDUF006ASDUF019ASDUF026ASDUF033ASDUF042ASDUF059ASDUF063
- 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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