FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: ReliOn 0.5cc 30 g x 8mm Blister Pak U-100 syringe 30 gauge x 5/16" length, for subcutaneous injection of insulin.
- Recall number
- Z-1226-2007
- Recalling firm
- Becton Dickinson & Company
- Product
- ReliOn 0.5cc 30 g x 8mm Blister Pak U-100 syringe 30 gauge x 5/16" length, for subcutaneous injection of insulin.
- Status
- Terminated
- Initiated
- 2007-06-21
- Posted
- 2007-09-20
- Terminated
- 2008-06-03
- Reason
- Complaints received indicating open seals on blister paks, potentially compromising the sterility of the product.
- Root cause
- Other
- Action
- Urgent Product Recall notifications were sent on 6/21/07 asking them to discontinue use of product, remove from inventory and complete Tracking Verification form.
- Quantity
- 644,500 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- Catalog number 326743, Batch number 6297350
- 510(k) numbers
- ["K024112"]
- PMA numbers
- not on file
- Product code
- FMI
- 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