Recalls / —

—#173047

Product

Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS

FDA product code

PND — Midline Catheter

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K161313

Affected lot / code info

Batch Code:13F17L0170

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 #173047. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.