Z-2728-2020Class II

Rusch Greenlite

Name: Z-2728-2020 Rusch Greenlite
Creator: Teleflex Medical Inc
Published: 2020-07-06
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2020-07-06 / Terminated / root cause: manufacturing process

FDA source

TELEFLEX MEDICAL INC began a recall of Rusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the... on 2020-07-06. FDA classified it as Class II and gives the reason as "Breaking at the point of a welded joint". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2728-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-06
Posted: 2020-07-28
Terminated: 2023-08-31
Recalling firm: Teleflex Medical
Product: Rusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Product code: CCW Laryngoscope, Rigid
Reason for recall: Breaking at the point of a welded joint
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Teleflex issued an Urgent Medical Device Recall on 07/06/2020. It states the following: 1. Immediately discontinue distribution and quarantine any products with the product code and lot number listed. 2. Using the provided customer letter and recall acknowledgement form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. 3. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. In the event that an alternative approach is needed, contact Teleflex Medical Customer Service for more information at 1-866-396-2111. 4. To return recalled products to Teleflex Medical, 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 the firm 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 product to Teleflex Medical. 5. Once you have completed returning all of the recalled products from your own inventory, and collecting and consolidating all of the recalled products from your customers, please check the box on the enclosed Recall Acknowledgment Form that indicates that you have completed the recall and fax it to 1-855-419-8507, Attn: Customer Service, or email it to [email protected]. This will allow to document completion of the recall. 6. If you and your customers 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 to document your receipt of this letter. If you have any other questions,contact your local sales representative or Customer Service at 1-866-396-2111.
Quantity in commerce: 7401 units
Distribution: US Nationwide distribution including in the states of FL, KY, CA, ND, UT, MA, MD, AZ, MS, TX, MI, WV, AL, MO, SC, VA, AR, PA, OK, NV, NM, NE, IN, IA, NY, GA, NJ, MN, IL, NC, NH, TN, ID, CO, HI, MT, OR, ME, CT, LA, OH, RI, SD, WA, DC, KS, AK.
Product codes and lots: Lot/Batch Numbers: 1812441 1901441 1903441 1905441 1906441 1907441 1909441

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2728-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2726-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-05	2020-07-28
Z-2727-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-05	2020-07-28
Z-2728-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-05	2020-07-28
Z-2729-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-05	2020-07-28
Z-2730-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-05	2020-07-28
Z-2731-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-05	2020-07-28
Z-2732-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-05	2020-07-28

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)