CLASS II Device recall · Reported 14 Sep 2016 · FDA Enforcement Report
Arterial Line Catheterization Kit recalled by Arrow International
Arrow International is recalling Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the, distributed nationwide in the US. The recall was initiated on 8 Aug 2016 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-2740-2016
- FDA event ID
- 74986
- Recalling firm
- Arrow International, Reading, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Aug 2016
- FDA classified
- 7 Sep 2016
- Reported
- 14 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 8 Aug 2016 | Recall initiated by company | |
| 7 Sep 2016 | Classified by FDA | +30 days |
| 14 Sep 2016 | 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
Shipping carton labeling error.
Product as listed by the FDA
Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vessels.
Where it was distributed
Nationwide Distribution to OH, IN, TN, NC, and KY.
Questions about this recall
Is Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the recalled?
Yes. Arrow International recalled Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the on 8 Aug 2016. The recall is Class II and its status is Terminated. Recall number Z-2740-2016.
Why was it recalled?
Shipping carton labeling error.
Which lots are affected?
Device Listing # D025180
Where was it sold?
Nationwide Distribution to OH, IN, TN, NC, and 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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