Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation.

FDA device recall Z-0705-2018 · posted 2018-02-23 · Terminated

Recall details

Recalling firm

Teleflex Medical

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.

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."

Root cause

Package design/selection

Status

Terminated

Product code

CCW

Quantity affected

2140 units

Distribution

US only

Date initiated

2017-01-10

Date posted

2018-02-23

Date terminated

2021-04-13

Location

Research Triangle Park, NC