Device product

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

Z-0705-2018

January 10, 2017

Class II

Product summary

Firm: Teleflex Medical
Event: Event 78929
Status: Terminated
Classification: Class II
Quantity: 2140 units
Official record key: device-enforcement:Z-0705-2018

Official wording

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.

Code information: Lot/Serial number: 1602312

Distribution pattern: US only

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.