CLASS II Device recall · Reported 15 Jan 2014 · FDA Enforcement Report
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle recalled
Smiths Medical ASD is recalling Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, distributed nationwide in the US. The recall was initiated on 10 Jul 2013 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-0646-2014
- FDA event ID
- 67034
- Recalling firm
- Smiths Medical ASD, Keene, NH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jul 2013
- FDA classified
- 8 Jan 2014
- Reported
- 15 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Syringes & Needles
Timeline
| 10 Jul 2013 | Recall initiated by company | |
| 8 Jan 2014 | Classified by FDA | +182 days |
| 15 Jan 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes
Product as listed by the FDA
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in. Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED052905IN Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.
Where it was distributed
Worldwide Distribution: US (nationwide) including states of: AZ, CA, FL, IL, LA, MO, MS, NH, NY, OH, PA, TN, TX, VA, WI, and WV; and countries of: Canada, Italy and Spain.
Nationwide ArizonaCaliforniaFloridaIllinoisLouisianaMissouriMississippiNew HampshireNew YorkOhioPennsylvaniaTennesseeTexasVirginiaWisconsinWest Virginia
Questions about this recall
Is Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe recalled?
Yes. Smiths Medical ASD recalled Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe on 10 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-0646-2014.
Why was it recalled?
Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes
Which lots are affected?
Lot Numbers: 2358702
Where was it sold?
Worldwide Distribution: US (nationwide) including states of: AZ, CA, FL, IL, LA, MO, MS, NH, NY, OH, PA, TN, TX, VA, WI, and WV; and countries of: Canada, Italy and Spain.
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 21 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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