CLASS II Device recall · Reported 21 Feb 2018 · FDA Enforcement Report
Radial Artery Catheterization Set recalled by Arrow International
Arrow International is recalling Radial Artery Catheterization Set &, device permits access to the peripheral arterial. The recall was initiated on 10 Jul 2017 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-0486-2018
- FDA event ID
- 78681
- Recalling firm
- Arrow International, Reading, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jul 2017
- FDA classified
- 13 Feb 2018
- Reported
- 21 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 10 Jul 2017 | Recall initiated by company | |
| 13 Feb 2018 | Classified by FDA | +218 days |
| 21 Feb 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
Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.
Where it was distributed
...
Questions about this recall
Why was it recalled?
Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.
Which lots are affected?
Lot Numbers: 1) 23F16H0859 & 2) 23F16J0547
Where was it sold?
...
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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Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
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| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |