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Port Access Needle recallZ-2669-2020 · 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-2669-2020
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 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 00801741066276), LH-0035YN (UDI 00801741066290 ), LH-0036YN (UDI 00801741066313), LH-0037YN (UDI 00801741066337), LH-0038YN (UDI 00801741066351), LH-0039YN (UDI 00801741066313), LH-0040YN (UDI 00801741066399)

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

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 00801741066276), LH-0035YN (UDI 00801741066290 ), LH-0036YN (UDI 00801741066313), LH-0037YN (UDI 00801741066337), LH-0038YN (UDI 00801741066351), LH-0039YN (UDI 00801741066313), LH-0040YN (UDI 00801741066399).   Lot Numbers: ASDQF068 ASDRF001 ASDRF002 ASDRF003 ASDRF005 ASEPF018 ASEPF019 ASEPF020 ASEPF026 ASEQF008 ASEQF025 ASEQF030 ASEQF039 ASEQF041 ASCYF038 ASCYF097 ASDQF065 ASDQF066 ASDQF067 ASDWF061 ASDWF062 ASDWF063 ASDWF064 ASDWF065 ASEQF045 ASEQF046 ASCYF039 ASCYF065 ASCYF093 ASCZF007 ASCZF008 ASCZF018 ASCZF019 ASCZF041 ASCZF042 ASDNF026 ASDQF027 ASDQF029 ASDQF037 ASDQF043 ASDQF051 ASDQF061 ASDRF037 ASDYF011 ASDYF016 ASDYF024 ASDYF034 ASDYF045 ASDYF055 ASDYF064 ASDYF066 ASDYF075 ASDYF078 ASDYF087 ASDZF073 ASDZF077 ASDZF087 ASDZF094 ASENF004 ASENF009 ASENF020 ASENF040 ASENF056 ASENF071 ASENF077 ASENF078 ASENF086 ASENF087 ASENF088 ASENF089 ASEPF001 ASEPF002 ASEPF003 ASEPF004 ASEPF005 ASCYF025 ASCYF026 ASCYF027 ASCZF028 ASDPF030 ASDQF016 ASDQF019 ASDQF024 ASDRF036 ASDZF014 ASDZF019 ASDZF023 ASDZF034 ASDZF040 ASDZF044 ASDZF052 ASDZF059 ASDZF067 ASEQF056 ASEQF069 ASEQF075 ASEQF076 ASCXF016 ASCXF017 ASDQF007 ASDQF010 ASDQF013 ASERF021 ASCXF014 ASCXF015 ASDPF038 ASDPF039 ASEQF108 ASEQF109 ASEQF111 ASEQF117 ASEQF121 ASEQF126 ASCYF096 ASDWF083 ASDWF084 ASEQF044 ASDRF007 ASDRF008 ASEQF042 ASCYF008 ASCYF009 ASCYF095 ASCZF030 ASDPF031 ASDPF032 ASCYF003 ASCYF004 ASDPF036 ASDPF037 ASEQF085 ASEQF093 ASEQF094 ASEQF095 ASERF041 ASCYF002 ASCYF094 ASDPF040 ASDPF041 ASCXF011 ASDNF044 ASDNF045 ASEQF100 ASEQF101 ASEQF102 ASEQF103 ASEQF104  Additional Lot as of 9/11/20: ASEQF034

Devices named in this recall

11 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

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