CLASS II Device recall · Reported 26 Sep 2018 · FDA Enforcement Report
single-lumen PICC Kit, Product recalled by Arrow International
Arrow International is recalling single-lumen PICC Kit, Product, distributed in 14 states. The recall was initiated on 17 Jul 2018 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-3199-2018
- FDA event ID
- 80839
- Recalling firm
- Arrow International, Reading, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jul 2018
- FDA classified
- 19 Sep 2018
- Reported
- 26 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 17 Jul 2018 | Recall initiated by company | |
| 19 Sep 2018 | Classified by FDA | +64 days |
| 26 Sep 2018 | 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
The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen catheter. This issue may cause a delay in treatment while a replacement catheter is obtained.
Product as listed by the FDA
4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2
Where it was distributed
The products were distributed to the following US states: AL, AZ, CA, GA, MA, MD, ME, MI, NY, PA, RI, SC, VA, and WA.
AlabamaArizonaCaliforniaGeorgiaMassachusettsMarylandMaineMichiganNew YorkPennsylvaniaRhode IslandSouth CarolinaVirginiaWashington
Questions about this recall
Is single-lumen PICC Kit, Product recalled?
Yes. Arrow International recalled single-lumen PICC Kit, Product on 17 Jul 2018. The recall is Class II and its status is Terminated. Recall number Z-3199-2018.
Why was it recalled?
The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen catheter. This issue may cause a delay in treatment while a replacement catheter is obtained.
Which lots are affected?
23F18B0428
Where was it sold?
The products were distributed to the following US states: AL, AZ, CA, GA, MA, MD, ME, MI, NY, PA, RI, SC, VA, and WA.
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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