CLASS II Device recall · Reported 29 Oct 2014 · FDA Enforcement Report
CRN Crono Syringe CRN20 withSteel Needle" recalled
Intra Pump Infusion Systems is recalling CRN Crono Syringe CRN20 withSteel Needle", distributed nationwide in the US. The recall was initiated on 18 Oct 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-0099-2015
- FDA event ID
- 66541
- Recalling firm
- Intra Pump Infusion Systems, Grapevine, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Oct 2013
- FDA classified
- 20 Oct 2014
- Reported
- 29 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 18 Oct 2013 | Recall initiated by company | |
| 20 Oct 2014 | Classified by FDA | +367 days |
| 29 Oct 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product has the potential to have a clear debris on the tip of the needle.
Product as listed by the FDA
CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"
Where it was distributed
Worldwide Distribution: US (nationwide) in states of CA, PA, MA, IL, OH and NY; and Internationally to Canada.
Nationwide CaliforniaIllinoisMassachusettsNew YorkOhioPennsylvania
Questions about this recall
Why was it recalled?
Product has the potential to have a clear debris on the tip of the needle.
Which lots are affected?
Product Code CRN20, lot numbers 14N02, 15E01, 15A02
Where was it sold?
Worldwide Distribution: US (nationwide) in states of CA, PA, MA, IL, OH and NY; and Internationally to Canada.
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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