Teleflex Medical Recalls TAUT Cholangiogram Catheter Intraducer Due to Missing Label
Teleflex Medical is recalling 611 units of TAUT Cholangiogram Catheter Intraducers because the internal packaging is missing labels. The devices were distributed to 27 states.
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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The specific defect is a missing label on internal packaging, which falls under documentation or packaging-only problems.
Plain-English summary
Teleflex Medical is recalling 611 units of TAUT Cholangiogram Catheter Intraducers, Peritoneal Catheters, and related accessories. The recall is due to a labeling defect where the internal packaging is missing the required label. These devices are intended to aid in the manipulation or insertion of medical devices into the body.
The affected products are identified by catalog number PI-128 and lot numbers 01C200424, 01C1200425, and 01C1200426. The recall was classified as Class III by the FDA, indicating that the use of or exposure to the product is not likely to cause adverse health consequences.
The devices were distributed to facilities in 27 states, including Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Pennsylvania, South Dakota, Texas, Utah, Virginia, Wisconsin, and West Virginia. Healthcare facilities should stop using the affected units and contact Teleflex Medical for instructions on return or replacement.
The recalled product
- Product
- TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research Triangle Park, NC. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body.
- Manufacturer
- Teleflex Medical
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 611
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 (3)
- Catalog number: PI-128
- Lot number: 01C200424
- 01C1200425 and 01C1200426.
Distribution
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