Device Recall ARROWgard Blue PLUS 의 리콜

Recall

79528

Class 2

Z-1152-2018

2017-12-21

2018-03-21

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162585

Certain lots may be missing information at the bottom of the lid including the lot number, expiration date, and unique device identification (udi) information.

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.