Device Recall Femoral Arterial Line Catheterization Kit 의 리콜

Recall

74489

Class 2

Z-2201-2016

2016-06-02

2016-07-12

Terminated

United States

2017-08-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147757

Labeling error. some shipping cartons labeled as ask-04018-vuh contained ask-04020-vuh kits; and some shipping cartons labeled as ask-04020-vuh contained ask-04018-vuh kits.

Arrow International mailed an Urgent Medical Device Recall Notification letter and acknowledgement form dated June 20, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above. 2. Inspect affected product within your control to identify if the shipping corrugate label correctly identifies the products inside the shipping carton. Products with an incorrect label on the shipping carton can be returned to Arrow. 3. Once you have completed inspection of all of the products from your own inventory, check the box on the enclosed Acknowledgment Form that indicates that you have completed the inspection and fax it to 1-855-419-8507, Attn: Customer Service, or email it to recalls@teleflex.com. For questions contact your local sales representative or Customer Service at 1-866-246-6990.