Palindrome Precision RT Chronic Catheter Kits Withdrawn for Labeling and Instruction Updates
Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits worldwide to implement point-of-use labeling and enhance device instructions for proper use.
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: This is a voluntary precautionary recall conducted to implement labeling improvements and instruction enhancements. No hazard is specified in the source text, no injuries or illnesses are reported, and the FDA classification is Class II, which meets the rubric criterion for Moderate severity (Score 2).
Plain-English summary
Covidien, LP is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits (Symmetrical Tip, Reverse-Tunneled, 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P) from worldwide distribution. The withdrawal affects 32 specific lot numbers.
The voluntary withdrawal is being conducted to implement point-of-use labeling on each device and to enhance the Instructions for Use (IFU).
Healthcare facilities and patients using this device should contact Covidien for information about the withdrawal and available options or replacements.
The recalled product
- Product
- Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P
- Manufacturer
- Covidien, LP
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 18 recalled by Covidien, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 18 products in this recall →Related recalls
Same manufacturer · Covidien, LP
See all →- SevereSurgipro II Sutures Recalled for Potential Sterile Barrier Defects
FDA (Devices) · 2026-08-19
- SevereDermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
Same hazard · labeling deficiency
See all →- Moderate
- ModerateDefibtech Automated External Defibrillators Model DDU-2300 Recalled
FDA (Devices) · 2025-05-07
- ModerateZimmer Biomet Ceramic Hip Head 22.2 mm Lacks Stem Compatibility Information
FDA (Devices) · 2025-04-30
- ModerateBD PYXIS MEDBANK Medication Systems: Labeling Update for Operating Room Restriction
FDA (Devices) · 2025-03-05
- ModerateBD PYXIS medication cabinets labeling update: operating room contraindication
FDA (Devices) · 2025-03-05