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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
- Hazard
- 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
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