FDA Recall Terminated

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

Recall: Z-0705-2018 · Initiated January 10, 2017

Recall

Recall Number
Z-0705-2018
Event Number
78929
Firm
Teleflex Medical
FEI Number
3005747797
Product Code
CCW
Status
Terminated
Root Cause
Package design/selection
Initiated
January 10, 2017
Posted
February 23, 2018
Terminated
April 13, 2021
Address
2917 Weck Dr, Research Triangle Park, NC, 27709-0186

Description

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

Reason

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

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 [email protected]. 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 [email protected]. This will allow us to document your receipt of this letter."

Distribution

US only

Quantity

2140 units