Recall Z-2130-2014
Teleflex Medical · initiated June 30, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical.
Codes / 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.
Reason for recall
There is a possibility the handle of the laryngoscope may heat up and melt the end cap.
FDA-determined cause: Device Design
Action taken
Consignees were notified via letter on/about 06/30/2014.
Details
- Recall number
- Z-2130-2014
- Initiated
- June 30, 2014
- Posted by FDA
- July 29, 2014
- Terminated
- March 21, 2017
- Product code
- CCW – Laryngoscope, Rigid
- Quantity
- 6,246 units
- Distribution
- U.S. Nationwide
- Recalling firm
- Teleflex Medical, Durham, NC