FDAClass IIAugust 6, 2014

RUSCH, TruLite, One-Piece Disposable Laryngoscope recall

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

Why was RUSCH, TruLite, One-Piece Disposable Laryngoscope recalled?

There is a possibility the handle of the laryngoscope may heat up and melt the end cap.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical.
Recalling firm
Teleflex Medical
Quantity
6,246 units
Distribution
U.S. Nationwide
Recall date
August 6, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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