—#175812

Product

8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: The MACTM Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K011761
Affected lot / code info: Lot Number: 13F18H0610

Why it was recalled

Products may contain the incorrect banner card within the kit

Root cause (FDA determination)

Packaging process control

Action the firm took

Arrow International issued notification dated 8/6/19 stating problem, health risk and action to take: If you have affected stock in inventory, immediately discontinue use and quarantine any products with the product codes and lot numbers. 2. Inspect affected products within your control to confirm the product code on the lidstock matches the product code on the banner card of the same kit. Products confirmed to have an incorrect banner card should be returned to Arrow International. Products which properly match should not be returned. 3. If you have product with an incorrect banner card, please complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. 4. If you have no affected stock, please complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. Questions, feel free to 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: US Nationwide distribution.

Timeline

Recall initiated: 2019-08-06
Terminated: 2020-09-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #175812. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.