FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: 1.0mL 28 G x 1/2" blister packaged insulin syringe Catalog Number 329424; Lot Number 0039920 Intended use: Subcutaneous injection of insulin.
- Recall number
- Z-0174-2012
- Recalling firm
- Becton Dickinson & Company
- Product
- 1.0mL 28 G x 1/2" blister packaged insulin syringe Catalog Number 329424; Lot Number 0039920 Intended use: Subcutaneous injection of insulin.
- Status
- Terminated
- Initiated
- 2011-06-15
- Posted
- 2011-11-07
- Terminated
- 2015-07-27
- Reason
- Experiment labels may be on shelf cartons of 1.0ml 28G x 1/2 blister packaged insulin syringes.
- Root cause
- Labeling mix-ups
- Action
- The firm, BD, sent an "PRODUCT RECALL NOTIFICATION" letter and response form dated June 15, 2011 to their consignee/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately review their inventory for the affected product, remove the product from inventory, quarantine the product and return it to BD; if the product was further distributed, they should identify their customers and notify them at once, and complete and return the attached Tracking/Verification Form via fax to: 201-847-4853. If you have any questions, contact Customer Service at 1-800-237-2762, Monday -Thursday, 8:00am-6:30pm and on Friday, 8:00-5:30pm Eastern Standard Time.
- Quantity
- 10,230 shelf cartons (1,0230,000 syringes)
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- K024112 D039612 Catalog Number 329424 Lot Number 0039920
- 510(k) numbers
- ["K024112"]
- PMA numbers
- not on file
- Product code
- KZH
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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