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FDA Medical Device Recalls (openFDA)

Becton Dickinson & Company: BD 20 ml Syringe Luer-Lok Tip Sterile, Do not reuse; Catalog Number 309661.

Recall number
Z-1488-2009
Recalling firm
Becton Dickinson & Company
Product
BD 20 ml Syringe Luer-Lok Tip Sterile, Do not reuse; Catalog Number 309661.
Status
Terminated
Initiated
2009-04-30
Posted
2009-06-24
Terminated
2009-09-28
Reason
Potential for compromised sterility: Insufficient packaging seals.
Root cause
Nonconforming Material/Component
Action
Becton Dickinson sent Urgent Product Recall letters on April 30, 2009 to all direct customers. Questions are to be directed to BD Customer Service at 1-888-237-2762. Letters to customers of distributors went out on May 12, 2009.
Quantity
201,600 units
Distribution
Nationwide Distribution.
Lot, serial or model codes
Catalog Number 309661: Lot numbers: 9065361, 9065362, 9065366, 9065367, 9065380.
510(k) numbers
not on file
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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