Recalls / —
—#173044
Product
Arrow JACC with Chlorag+ard Technology Product Code:JR 42563 HPHNM
- FDA product code
- LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K132133
- Affected lot / code info
- Batch Code: 13F17F0099
Why it was recalled
Lidstock states the incorrect expiration date for the product
Root cause (FDA determination)
Process control
Action the firm took
Arrow International initiated recall by letter dated April 23,2019 described the problem, health risk and action to take: If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Complete the enclosed Acknowledgement Form indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. Distributors requested to subrecall. Questions, contact your local sales representative or Customer Service at 1-866-396-2111.
Recalling firm
- Firm
- Arrow International Inc
- Address
- 2400 Bernville Rd, Reading, Pennsylvania 19605-9607
Distribution
- Distribution pattern
- Nationwide Foreign:
Timeline
- Recall initiated
- 2019-04-23
- Terminated
- 2021-01-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #173044. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.