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FDA Medical Device Recalls (openFDA)

Becton Dickinson & Company: BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062

Recall number
Z-2747-2017
Recalling firm
Becton Dickinson & Company
Product
BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
Status
Terminated
Initiated
2016-09-16
Posted
not on file
Terminated
2018-03-20
Reason
BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
Root cause
Process control
Action
BD sent recall letter/return response form on 9/16/2016.
Quantity
22,400 units
Distribution
Nationwide Distribution
Lot, serial or model codes
6204878 2021-07
510(k) numbers
["K110771"]
PMA numbers
not on file
Product code
FMF
Firm FEI
2243072
Firm city
Franklin Lakes
Firm state
NJ
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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