Recalls / —
—#128462
Product
RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical.
- FDA product code
- CCW — Laryngoscope, Rigid
- Device class
- Class 1
- Medical specialty
- Anesthesiology
- Affected lot / code info
- 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.
Why it was recalled
There is a possibility the handle of the laryngoscope may heat up and melt the end cap.
Root cause (FDA determination)
Device Design
Action the firm took
Consignees were notified via letter on/about 06/30/2014.
Recalling firm
- Firm
- Teleflex Medical
- Address
- 4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000
Distribution
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2014-06-30
- Posted by FDA
- 2014-07-29
- Terminated
- 2017-03-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #128462. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.