FDA Medical Device Recalls (openFDA)
Arrow International Inc: ArrowClarke" PleuraSeal Thoracentesis Kit
- Recall number
- Z-1298-2018
- Recalling firm
- Arrow International Inc
- Product
- ArrowClarke" PleuraSeal Thoracentesis Kit
- Status
- Terminated
- Initiated
- 2017-10-24
- Posted
- not on file
- Terminated
- 2020-04-17
- Reason
- Product packaging may not be completely sealed.
- Root cause
- Component design/selection
- Action
- On October 24, 2017 and Urgent Medical Device Recall letter was issued to customers to review inventory and if there's any affected stock, to immediately discontinue use, quarantine and prepare to return to recalling firm. Questions or concerns can be directed to 1-855-419-8507 or 1-866-246-6990
- Quantity
- not on file
- Distribution
- Nationally
- Lot, serial or model codes
- AK01000 AK-01000-J AK-01000-T ASK-01000-CHP
- 510(k) numbers
- ["K870572"]
- PMA numbers
- not on file
- Product code
- KDD
- Firm FEI
- 3015859709
- Firm city
- Reading
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28