FDA Medical Device Recalls (openFDA)
Teleflex Medical: RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical.
- Recall number
- Z-2130-2014
- Recalling firm
- Teleflex Medical
- Product
- RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical.
- Status
- Terminated
- Initiated
- 2014-06-30
- Posted
- 2014-07-29
- Terminated
- 2017-03-21
- Reason
- There is a possibility the handle of the laryngoscope may heat up and melt the end cap.
- Root cause
- Device Design
- Action
- Consignees were notified via letter on/about 06/30/2014.
- Quantity
- 6,246 units
- Distribution
- U.S. Nationwide
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CCW
- Firm FEI
- 3005747797
- Firm city
- Durham
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28