CLASS II Device recall · Reported 30 Apr 2014 · FDA Enforcement Report
Arrowgard Blue Plus Antimicrobial Multi-lumen Central recalled
Arrow International is recalling Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, distributed in 12 states. The recall was initiated on 17 Jul 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-1507-2014
- FDA event ID
- 67834
- Recalling firm
- Arrow International, Reading, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jul 2013
- FDA classified
- 24 Apr 2014
- Reported
- 30 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 17 Jul 2013 | Recall initiated by company | |
| 24 Apr 2014 | Classified by FDA | +281 days |
| 30 Apr 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due to a labeling inconsistency. One portion of the lidstock states that the kit contains 8.5FR x 16CM catheter, while the rest of the lidstock correctly identifies the catheter as 8.5FR x 20CM
Product as listed by the FDA
Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC.
Where it was distributed
US Distribution including the states of IA, OR, WV, MI, AZ, IL, PA, GA, DE, NC, LA, and VA.
ArizonaDelawareGeorgiaIowaIllinoisLouisianaMichiganNorth CarolinaOregonPennsylvaniaVirginiaWest Virginia
Questions about this recall
Is Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter recalled?
Yes. Arrow International recalled Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter on 17 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-1507-2014.
Why was it recalled?
Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due to a labeling inconsistency. One portion of the lidstock states that the kit contains 8.5FR x 16CM catheter, while the rest of the lidstock correctly identifies the catheter as 8.5FR x 20CM
Which lots are affected?
lot RF2110924
Where was it sold?
US Distribution including the states of IA, OR, WV, MI, AZ, IL, PA, GA, DE, NC, LA, and VA.
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.
More recalls from Arrow International
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|---|---|---|---|---|---|
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| Device | CLASS I | Description/REF: Hemodialysis KIT: 2-Lumen 8 FR X 11 CM/AK-11802-F recalled | Arrow International | Lead & Heavy Metals | Nationwide |
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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 |
| Device | CLASS I | Description/REF: Pacing PSI KIT: 6 FR/AI-06210-KS, Pacing PSI KIT recalled | Arrow International | Lead & Heavy Metals | Nationwide |
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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 |
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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 |