ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS catheter permits ven

FDA device recall Z-1152-2018 · posted 2018-03-21 · Terminated

Recall details

Recalling firm

Arrow International Inc

Reason for recall

Certain lots may be missing information at the bottom of the lid including the lot number, expiration date, and Unique Device Identification (UDI) information.

Action taken

Arrow International sent Notification letters to DISTRIBUTORS that include the following instructions: 1. Discontinue distribution and quarantine any affected products. 2. Inspect affected products to identify whether they have the lot number, expiration date, and UDI information. Products missing this information should be returned. 3. Using the provided Customer Letter and Acknowledgement Form templates, communicate this recall to any customers who have received affected products. Customers should return mislabeled products. Products that are properly labeled should not be returned. 4. Any customers with mislabeled products should return them with a completed Acknowledgement Form. 6. If you and customers have no affected stock please complete and return the Acknowledgment Form. Notification letters to RISK MANAGERS include the following instructions: 1. Discontinue use and quarantine any affected products. 2. Inspect affected products and identify whether they have the lot number, expiration date, and UDI information. Products missing this information should be returned to the Distributor. 3. Complete the Acknowledgement Form whether or not there is affected product that must be returned. For questions contact your local sales representative or Customer Service at 1-866-246-6990.

Root cause

Process control

Status

Terminated

Product code

FOZ

Quantity affected

420

Distribution

United States in the state of FL.

Date initiated

2017-12-21

Date posted

2018-03-21

Date terminated

2020-04-20

Location

Reading, PA

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