The Recall Desk
ModerateFDA (Devices)·Z-1732-2014·Announced 2014-06-18

Teleflex Recalls RUSCH Easy Cath Coude Kits Due to Incorrect Catheter Type

Teleflex Medical is recalling 1,000 RUSCH Easy Cath Coude Kits because they were packaged with straight catheters instead of the required curved ones.

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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a packaging error resulting in the wrong device type, which is a moderate risk compared to active contamination or structural failure.

Plain-English summary

Teleflex Medical is recalling 1,000 units of the RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile. The product is a tubular device inserted through the urethra to pass fluids to or from urinary tracts. The specific product code is ECK103 and the lot number is 02A1402484.

The recall was initiated because the product was packaged with a straight catheter rather than the correct coude (curved) catheter. This packaging error means the device does not match the specific anatomical configuration intended for the 'Coude' kit.

The affected units were distributed in the United States, including the states of California, Florida, Ohio, and Oklahoma. Healthcare providers and patients who have received this specific lot should stop using the product and contact Teleflex Medical for further instructions.

The recalled product

Product
RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is inserted through the urethera and is used to pass fluids to or from urinary tracts.
Manufacturer
Teleflex Medical
Affected units
1,000

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 (2)

  • Product Code: ECK103
  • Lot number: 02A1402484

Distribution

Distributed in 4 states: