CLASS II Device recall · Reported 11 Apr 2018 · FDA Enforcement Report
ArrowClarke" PleuraSeal¿ Thoracentesis Kit recalled
Arrow International is recalling ArrowClarke" PleuraSeal¿ Thoracentesis Kit, distributed nationwide in the US. The recall was initiated on 24 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-1298-2018
- FDA event ID
- 79294
- Recalling firm
- Arrow International, Reading, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Oct 2017
- FDA classified
- 3 Apr 2018
- Reported
- 11 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 24 Oct 2017 | Recall initiated by company | |
| 3 Apr 2018 | Classified by FDA | +161 days |
| 11 Apr 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
Product packaging may not be completely sealed.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
ArrowClarke" PleuraSeal¿ Thoracentesis Kit
Where it was distributed
Nationally
Questions about this recall
Is ArrowClarke" PleuraSeal¿ Thoracentesis Kit recalled?
Yes. Arrow International recalled ArrowClarke" PleuraSeal¿ Thoracentesis Kit on 24 Oct 2017. The recall is Class II and its status is Terminated. Recall number Z-1298-2018.
Why was it recalled?
Product packaging may not be completely sealed.
Which lots are affected?
AK01000 AK-01000-J AK-01000-T ASK-01000-CHP
Where was it sold?
Nationally
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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