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.
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 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
Related recalls
Same manufacturer · Teleflex Medical
See all →- LowTeleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
- LowTeleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
- ModerateTeleflex Sheridan Endobronchial Tubes Recalled for Incorrect Labeling
FDA (Devices) · 2019-12-25
- HighTeleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
- HighTeleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02