Z-2130-2014Class II

RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed...

Name: Z-2130-2014 RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed...
Creator: Teleflex Medical
Published: 2014-06-30
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2014-06-30 / Terminated / root cause: design

FDA source

Teleflex Medical began a recall of RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical on 2014-06-30. FDA classified it as Class II and gives the reason as "There is a possibility the handle of the laryngoscope may heat up and melt the end cap". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2130-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-30
Posted: 2014-07-29
Terminated: 2017-03-21
Recalling firm: Teleflex Medical
Product: RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical.
Product code: CCW Laryngoscope, Rigid
Reason for recall: There is a possibility the handle of the laryngoscope may heat up and melt the end cap.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were notified via letter on/about 06/30/2014.
Quantity in commerce: 6,246 units
Distribution: U.S. Nationwide
Product codes and lots: Product Code: 004660000, (Size Miller 0), Lot numbers: 1306602, 1308602 & 1310602; Product Code: 004660001, (Size Miller 1), Lot numbers: 1306612, 1308612 & 1310612; Product Code: 004660002, (Size Miller 2), Lot numbers: 1306622, 1308622, 1309622 & 1310622; Product Code: 004660003, (Size Miller 3), Lot numbers: 1306632 & 1310632; Product Code: 004660004, (Size Miller 4), Lot numbers: 1306642, 1308642 & 1309642; Product Code: 004660010, (Size Miller 00), Lot numbers: 1306592, 1308592, 1309592, 1312592 & 1401592; Product Code: 004661002, (Size Mac 2), Lot numbers: 1306522, 1308522 & 1310522; Product Code: 004661003, (Size Mac 3), Lot numbers: 1306532, 1308532 & 1310532 and Product Code: 004661004, (Size Mac 4), Lot numbers: 306542, 1308542 & 1309542.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2130-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2130-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-06	2014-07-29

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)