ARROW INTERNATIONAL Inc. Arrow Three-Lumen CVC Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Gravity flow rates on the affected product lidstock are incorrect.

Recommended Action

Per FDA guidance

A recall notification was issued to the consignee on 05/05/2022 via FedEx 2-day mail. The letter instructs the consignee to check the inventory, place a copy of the letter with all affected product and return the response form if the consignee is a medical facility. If the consignee is a distributor, the letter instructs the consignee to provide the notice to their customers, check the inventory, return the completed response form. An updated notification was sent on about 08/09/2022, via FedEx. The updated notification provided an additional description of the label error. Product scope remains the same.