Z-0705-2018Class II

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

Name: Z-0705-2018 Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation
Creator: Teleflex Medical
Published: 2017-01-10
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2017-01-10 / Terminated / root cause: packaging

FDA source

Teleflex Medical began a recall of Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation on 2017-01-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0705-2018
Classification: Class II
Status: Terminated
Initiated: 2017-01-10
Posted: 2018-02-23
Terminated: 2021-04-13
Recalling firm: Teleflex Medical
Product: Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation.
Product code: CCW Laryngoscope, Rigid
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.
Root cause tag: packaging
FDA root cause: Package design/selection
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."
Quantity in commerce: 2140 units
Distribution: US only
Product codes and lots: Lot/Serial number: 1602312

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0705-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0705-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-23

Product code CCW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)