The Recall Desk
ModerateFDA (Devices)·Z-1851-2014·Announced 2014-07-02

Teleflex Medical Recalls RUSCH LaserTube Tracheal Tubes for Missing Latex Warning

Teleflex Medical is recalling RUSCH LaserTube tracheal tubes because the label failed to print a specific caution statement regarding natural rubber latex.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a labeling omission regarding a known allergen without reporting any specific illnesses or injuries, fitting the criteria for a moderate severity labeling error.

Plain-English summary

Teleflex Medical is recalling RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tubes, cuffed. The recall involves 1,658 units distributed nationwide and in Colombia. The product is a medical device inserted into a patient's trachea to maintain an open airway.

The recall was initiated because, although the Natural Rubber Latex caution symbol was clearly displayed on the product label, the accompanying caution statement "Caution: This product contains Natural Rubber Latex which may cause Allergic Reactions" was not printed on the label. This omission means patients and healthcare providers may not be fully informed about the potential for allergic reactions associated with the natural rubber latex content.

Healthcare providers and patients who have used or possess these specific tracheal tubes should contact Teleflex Medical for further instructions. The affected lots include specific product codes and lot numbers detailed in the recall notice.

The recalled product

Product
RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.
Manufacturer
Teleflex Medical
Affected units
1,658

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Product Code: 102004040
  • Lot #13371
  • 13381
  • 13291
  • 13281
  • 13251 & 13231
  • Product Code: 102004050
  • Lot #13461
  • 13441
  • 13401
  • 13431
  • 13421
  • 13371
  • 1329
  • 13301
  • 13311
  • 13361
  • 13261
  • 13231
  • 13251 & 13241

Distribution

Distributed nationwide across the United States.