The Recall Desk
LowFDA (Devices)·Z-2154-2014·Announced 2014-08-13

Teleflex Recalls RUSCH Foley Urinary Catheter Insertion Trays Due to Labeling Error

Teleflex Medical is recalling 720 RUSCH Foley Urinary Catheter Insertion Trays because the expiration date is incorrectly printed as the same as the manufacturing date.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding the expiration date.

Plain-English summary

Teleflex Medical is recalling 720 units of RUSCH Foley Urinary Catheter Insertion Trays (Product Code: 76730, Lot number: 307505). The recall is due to a labeling error where the expiration date is incorrectly printed to be the same as the manufacturing date. The manufacturing date is correct, but the expiration date incorrectly indicates that the product is expired.

The affected products were distributed nationwide in California, Connecticut, Florida, Massachusetts, Missouri, New Jersey, Ohio, Oregon, and Texas. The products are sterile, prescription-only medical devices containing a 10cc syringe and BZK swabs.

Healthcare providers and consumers should stop using the affected lots and contact Teleflex Medical for further instructions or a replacement.

The recalled product

Product
RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.
Manufacturer
Teleflex Medical
Affected units
720

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: 76730
  • Lot number: 307505.

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically: