—#156669

Product

Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node

FDA product code: OBJ — Catheter, Ultrasound, Intravascular
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K103255
Affected lot / code info: Lot/Batch Numbers: 23F16M0017

Why it was recalled

There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

Arrow International sent an Urgent Medical Device Recall Notification letter dated June 1, 2017, and Recall Acknowledgement Form to their domestic consignees via FedEx 2-day. Customers were advised to immediately inspect stock, discontinue use and quarantine any products with the product codes and lot numbers listed, so that the affected products can be returned to Arrow. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow the firm to document the amount of product you have on hand for return. A customer service representative will the customer with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Arrow International. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow the company to document your receipt of the letter. Customers that have any questions can contact their local sales representative or Customer Service at 1-866-246-6990.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern: Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD

Timeline

Recall initiated: 2017-06-01
Terminated: 2020-04-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #156669. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.