CLASS II Device recall · Reported 11 Jul 2018 · FDA Enforcement Report
Multi-Lumen Central Venous Catheterization Set recalled
Arrow International is recalling Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E, distributed nationwide in the US. The recall was initiated on 11 May 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-2336-2018
- FDA event ID
- 80227
- Recalling firm
- Arrow International, Reading, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 May 2018
- FDA classified
- 29 Jun 2018
- Reported
- 11 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Heart & Vascular Devices
Timeline
| 11 May 2018 | Recall initiated by company | |
| 29 Jun 2018 | Classified by FDA | +49 days |
| 11 Jul 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The recalling firm has received complaints related to increased resistance encountered when introducing the CVC over the spring wire guide. This may lead to procedural delay, and there may be need of medical intervention by exchanging the catheter for another CVC catheter.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single puncture site by way of the femoral, jugular, or subclavian veins.
Where it was distributed
Distributor in FL. International distribution to Czech Republic, Dominican Republic, France, Greece, and Italy.
Questions about this recall
Is Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E recalled?
Yes. Arrow International recalled Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E on 11 May 2018. The recall is Class II and its status is Terminated. Recall number Z-2336-2018.
Why was it recalled?
The recalling firm has received complaints related to increased resistance encountered when introducing the CVC over the spring wire guide. This may lead to procedural delay, and there may be need of medical intervention by exchanging the catheter for another CVC catheter.
Which lots are affected?
71F18A0682
Where was it sold?
Distributor in FL. International distribution to Czech Republic, Dominican Republic, France, Greece, and Italy.
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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