Recall Z-0705-2018

Reason for recall

The pouch may contain the incorrect Rusch Green Lite product size. Pouches that are labeled as containing RUSCH GREEN LITE MAC 1 may instead contain RUSCH GREEN LITE MAC 2.

FDA-determined cause: Package design/selection

Action taken

The firm initiated their recall by letter on 01/10/2018 via FedEx 2-day. Affected consignees were instructed to take the following actions: "1. If you have affected stock, immediately discontinue use and quarantine any products with the product code and lot number listed above, so that the affected products can be returned to Teleflex. 2. 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 us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. 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 us to document your receipt of this letter."