CLASS II Device recall · Reported 21 Oct 2015 · FDA Enforcement Report
Distal Access Catheters - 044 -: Finished Good Number recalled
Concentric Medical is recalling Distal Access Catheters - 044 -: Finished Good Number 90960-001, distributed in Kentucky. The recall was initiated on 19 Aug 2015 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-0116-2016
- FDA event ID
- 72247
- Recalling firm
- Concentric Medical, Mountain View, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Aug 2015
- FDA classified
- 9 Oct 2015
- Reported
- 21 Oct 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 19 Aug 2015 | Recall initiated by company | |
| 9 Oct 2015 | Classified by FDA | +51 days |
| 21 Oct 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
One Distal Access Catheter intended for distribution in Korea, was found at a US location.
Product as listed by the FDA
Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.
Where it was distributed
US Distribution to one location in KY.
Questions about this recall
Is Distal Access Catheters - 044 -: Finished Good Number 90960-001 recalled?
Yes. Concentric Medical recalled Distal Access Catheters - 044 -: Finished Good Number 90960-001 on 19 Aug 2015. The recall is Class II and its status is Terminated. Recall number Z-0116-2016.
Why was it recalled?
One Distal Access Catheter intended for distribution in Korea, was found at a US location.
Which lots are affected?
Lot no. 37603 Expiration date: September 2016
Where was it sold?
US Distribution to one location in KY.
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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