CLASS II Device recall · Reported 28 Feb 2018 · FDA Enforcement Report
Arrow Multi Lumen CVC Kit (Central venous catheter) recalled
Arrow International is recalling Arrow Multi Lumen CVC Kit (Central venous catheter), distributed nationwide in the US. The recall was initiated on 17 Oct 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-0654-2018
- FDA event ID
- 79197
- Recalling firm
- Arrow International, Reading, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Oct 2017
- FDA classified
- 20 Feb 2018
- Reported
- 28 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 17 Oct 2017 | Recall initiated by company | |
| 20 Feb 2018 | Classified by FDA | +126 days |
| 28 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
These finished good kits may contain the incorrect Springwire Guide (SWG).
Product as listed by the FDA
Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018
Where it was distributed
Distribution US Nationwide
Questions about this recall
Is Arrow Multi Lumen CVC Kit (Central venous catheter) recalled?
Yes. Arrow International recalled Arrow Multi Lumen CVC Kit (Central venous catheter) on 17 Oct 2017. The recall is Class II and its status is Terminated. Recall number Z-0654-2018.
Why was it recalled?
These finished good kits may contain the incorrect Springwire Guide (SWG).
Which lots are affected?
Lot number: 13F16M0241
Where was it sold?
Distribution US Nationwide
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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| Device | CLASS I | Description/REF: PI Picc: 3: 6FR x 55CM w CHG/ Dlx-35563-Hpkc; Agba recalled | Arrow International | Lead & Heavy Metals | Nationwide |
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| 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 |