Recalls / —
—#161832
Product
Large Volume Abdominal Paracentesis Kit
- FDA product code
- KDD — Kit, Surgical Instrument, Disposable
- Device class
- Class 1
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K874063
- Affected lot / code info
- AK 00376
Why it was recalled
Product packaging may not be completely sealed.
Root cause (FDA determination)
Component design/selection
Action the firm took
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
Recalling firm
- Firm
- Arrow International Inc
- Address
- 2400 Bernville Rd, Reading, Pennsylvania 19605-9607
Distribution
- Distribution pattern
- Nationally
Timeline
- Recall initiated
- 2017-10-24
- Terminated
- 2020-04-17
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #161832. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.