Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation.
FDA Recall Z-0705-2018 · Posted 2018-02-23
Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeCCW
Date Initiated2017-01-10
Date Terminated2021-04-13
Product Quantity2140 units
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.
Firm 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."
Root Cause
Package design/selection
Distribution Pattern
US only
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.