FDA Medical Device Recalls (openFDA)
Cypress Medical Products LLC: McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.
- Recall number
- Z-0119-2019
- Recalling firm
- Cypress Medical Products LLC
- Product
- McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.
- Status
- Terminated
- Initiated
- 2018-09-04
- Posted
- not on file
- Terminated
- 2024-05-28
- Reason
- Small hole at the end of the syringe is impeding suction of liquid.
- Root cause
- Equipment maintenance
- Action
- Cypress Medical Products LLC notified the distributor, McKesson Medical-Surgical, on 9/4/18. McKesson Medical-Surgical is responsible for communications to the distribution centers and end users. Any material on hand at end user facilities will be returned to the McKesson DC. Accounts requested to cease distribution and quarantine product for return. A response form included with letter to be completed and returned.
- Quantity
- 400 cases
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Lot Code: KSH0603
- 510(k) numbers
- ["K993017"]
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 1451040
- Firm city
- Richmond
- Firm state
- VA
- 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