Z-0119-2019Class II

McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P

Name: Z-0119-2019 McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P
Creator: Cypress Medical Products LLC
Published: 2018-09-04
License: https://open.fda.gov/license/

Cypress Medical Products LLC / initiated 2018-09-04 / Terminated / root cause: manufacturing process

FDA source

Cypress Medical Products LLC began a recall of McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only on 2018-09-04. FDA classified it as Class II and gives the reason as "Small hole at the end of the syringe is impeding suction of liquid". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0119-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-04
Posted: 2018-10-16
Terminated: 2024-05-28
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.
Product code: FMF Syringe, Piston
Reason for recall: Small hole at the end of the syringe is impeding suction of liquid.
Root cause tag: manufacturing process
FDA 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 in commerce: 400 cases
Distribution: US Nationwide Distribution
Product codes and lots: Lot Code: KSH0603

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0119-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0119-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-16

Product code FMF

K993017Class IIProfi Disposable Syringe, Profi Disposable Needle, Dm Ject Insulin SyringeShinchang Medical Co., Ltd. / cleared 2000-02-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)