Skip to content

Port Access Needle recallZ-2671-2020 · Becton Dickinson & Company · initiated Jun 19, 2020

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Process control

What the company is doing

URGENT MEDICAL DEVICE RECALL notification letters dated 6/19/20 were sent to customers. PLEASE TAKE THE FOLLOWING ACTIONS: 1. Immediately review your inventory for the specific catalog and lot numbers referenced in Attachment A. Discontinue use of those devices and destroy all product subject to this recall following your institutions process for destruction. MDS-20-1979 Page 2 of 28 BD Medical 1 Becton Drive Franklin Lakes, NJ 07417 USA bd.com 2. Share this notification with all users of the product within your facility network to ensure they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements and subsequently process your credit accordingly for the discarded material. a. Customers who purchased product directly from BD will receive credit. b. Customers who did not purchase product directly from BD will need to contact their distributor to obtain credit. 4. Report any adverse health consequences experienced with the use of this product to BD at [email protected]. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1800FDA1088 (18003321088) Mail: MedWatch, HF2, FDA, 5600 Fishers Lane, Rockville, MD 208529787 Customer/Technical Support Phone: 8002901689 Monday Friday between 8:00 am to 5:00 pm MDT [email protected] An Urgent Medical Device Recall notification letter dated 8/25/20 was sent to customers informing them of two additional lots of affected product. An URGENT MEDICAL DEVICE RECALL UPDATE dated 10/7/20 was sent to customers informing them of two additional lots of affected product.

Recall details

Recall number
Z-2671-2020
Status
Terminated
Initiated by the company
Jun 19, 2020
Posted by the FDA
Jul 20, 2020
Recalling firm
Becton Dickinson & Company
Quantity
5,296,132 total
Product code
PTI
FDA submissions
K153440
Distribution
Worldwide Distribution

Product description

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 00801741066306), LH-0037 (UDI 00801741066320), LH-0038 (UDI 00801741066344), LH-0039 (UDI 00801741066368), LH-0040 (UDI 00801741066382)

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

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 00801741066306), LH-0037 (UDI 00801741066320), LH-0038 (UDI 00801741066344), LH-0039 (UDI 00801741066368), LH-0040 (UDI 00801741066382).   Lot Numbers: ASCYF001 ASCYF017 ASDRF018 ASDRF031 ASDRF040 ASDSF065 ASDSF070 ASDTF004 ASDTF007 ASDVF048 ASDVF054 ASDXF058 ASDXF060 ASDXF066 ASDYF071 ASDYF077 ASDYF098 ASDZF010 ASDZF017 ASDZF024 ASDZF035 ASDZF036 ASDZF046 ASDZF071 ASDZF081 ASDZF093 ASENF002 ASERF025 ASERF032 ASCYF015 ASCYF016 ASCZF027 ASDRF043 ASDRF044 ASDRF054 ASDRF055 ASDRF056 ASDVF058 ASDVF063 ASDXF020 ASDXF045 ASENF011 ASENF014 ASERF004 ASCYF089 ASCYF090 ASCYF091 ASCYF092 ASCZF009 ASCZF010 ASCZF011 ASCZF022 ASCZF023 ASCZF039 ASCZF040 ASCZF045 ASCZF054 ASDPF016 ASDQF035 ASDQF054 ASDQF055 ASDQF060 ASDQF064 ASDRF006 ASDRF014 ASDRF019 ASDRF032 ASDRF039 ASDRF069 ASDRF073 ASDRF087 ASDRF098 ASDSF003 ASDSF010 ASDSF016 ASDSF019 ASDSF022 ASDSF033 ASDSF047 ASDSF050 ASDSF057 ASDSF061 ASDSF069 ASDTF005 ASDTF008 ASDTF022 ASDVF051 ASDVF060 ASDVF071 ASDVF079 ASDVF091 ASDWF004 ASDWF013 ASDWF018 ASDWF034 ASDWF035 ASDWF036 ASDWF040 ASDWF041 ASDWF042 ASDWF046 ASDWF047 ASDWF048 ASDWF052 ASDWF053 ASDWF054 ASDWF058 ASDWF059 ASDWF060 ASDWF080 ASDWF090 ASDWF099 ASDWF121 ASDWF126 ASDXF006 ASDXF014 ASDXF053 ASDXF063 ASDXF070 ASDXF078 ASDXF092 ASDXF096 ASDXF101 ASDXF103 ASDXF106 ASDYF001 ASDYF004 ASDYF006 ASDYF009 ASDYF010 ASDYF015 ASDYF019 ASDYF023 ASDYF029 ASDYF033 ASDYF037 ASDYF044 ASDYF050 ASDYF054 ASDYF060 ASDYF061 ASDYF074 ASDYF082 ASDYF093 ASDZF004 ASDZF013 ASDZF058 ASDZF069 ASEPF012 ASEPF015 ASEPF017 ASEPF021 ASEQF001 ASEQF022 ASEQF026 ASEQF031 ASEQF066 ASEQF083 ASEQF092 ASEQF110 ASEQF132 ASERF013 ASERF022 ASDNF034 ASDNF049 ASDNF055 ASDPF015 ASDPF017 ASDPF021 ASDPF024 ASDPF025 ASDPF026 ASDQF017 ASDRF066 ASDUF120 ASDVF004 ASDVF009 ASDVF013 ASDVF016 ASDVF025 ASDVF028 ASDVF032 ASDVF052 ASDXF048 ASDXF052 ASDXF061 ASDXF068 ASDXF077 ASDXF091 ASDXF100 ASDXF107 ASDYF083 ASDYF088 ASEPF008 ASEPF011 ASEPF014 ASCXF012 ASCXF013 ASDSF006 ASDSF008 ASDSF012 ASDSF013 ASDSF021 ASDSF025 ASDWF110 ASDWF111 ASDWF116 ASDWF122 ASDXF003 ASENF058 ASEQF118 ASCYF011 ASCYF012 ASDRF099 ASDRF100 ASDRF101 ASDSF001 ASDSF005 ASDXF010 ASDXF011 ASDXF016 ASDXF079 ASENF051 ASCYF013 ASCYF014 ASCZF029 ASDVF034 ASDVF035 ASDVF038 ASDVF042 ASDVF044 ASDXF054 ASDXF055 ASENF030 ASENF033 ASENF034 ASENF042 ASCYF010 ASDRF059 ASDRF061 ASDRF062 ASDXF057 ASERF001 ASERF002 ASERF003 ASDQF008 ASDQF009 ASDQF011 ASDQF012 ASDTF100 ASDVF075 ASDXF090 ASDXF093 ASDPF043 ASDPF044 ASDPF045 ASDPF046 ASDQF001 ASDVF077 ASDVF078 ASDXF044 ASDXF047 ASCXF003 ASDSF063 ASDXF080 ASCXF004 ASDPF028 ASDSF064 ASDXF081 ASENF057  Additional lot as of 9/11/20: ASEQF035

Devices named in this recall

12 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 85853).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page