CLASS II Device recall · Reported 24 Oct 2018 · FDA Enforcement Report
McKesson Insulin Syringe 31GX5/16 recalled by Cypress Medical Products
Cypress Medical Products is recalling McKesson Insulin Syringe 31GX5/16, distributed nationwide in the US. The recall was initiated on 4 Sep 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0119-2019
- FDA event ID
- 81113
- Recalling firm
- Cypress Medical Products, Richmond, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Sep 2018
- FDA classified
- 16 Oct 2018
- Reported
- 24 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 4 Sep 2018 | Recall initiated by company | |
| 16 Oct 2018 | Classified by FDA | +42 days |
| 24 Oct 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Small hole at the end of the syringe is impeding suction of liquid.
Product as listed by the FDA
McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
Small hole at the end of the syringe is impeding suction of liquid.
Which lots are affected?
Lot Code: KSH0603
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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