Palindrome Precision Chronic Catheter Kit Recalled for Packaging Defect
Covidien LLC is recalling 150 units of Palindrome Precision Chronic Catheter Kits due to incorrect packaging with a 90-degree bend at the distal tip.
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: The recall is classified as FDA Class II, which typically corresponds to a moderate severity level involving temporary or medically reversible adverse health consequences, without reported serious injuries or deaths.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 150 units of the Palindrome Precision Chronic Catheter Kit, manufactured by Covidien LLC. The specific product affected is the Symmetrical Tip, Tal VenaTrac Stylet 14.5 Fr/Ch (4.8mm) X 33 cm, Item Number 8888145046C, Lot Number 1506100125. The recall is due to the product being incorrectly packaged with a 90-degree bend at the distal tip.
The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. The affected units were distributed worldwide, including the United States (nationwide), Canada, Belgium, Chile, Panama, Denmark, France, Germany, Netherlands, Spain, Switzerland, and the United Kingdom.
Healthcare providers and patients should stop using the affected catheters and contact the manufacturer or their supplier for further instructions. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145046C The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneousl
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Catheters
- Affected units
- 150
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 (1)
- Lot Numbers: 1506100125
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Covidien LLC 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 5 products in this recall →Related recalls
Same manufacturer · Covidien LLC
See all →- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- ModerateCovidien Shiley Disposable Decannulation Plug product labeling error
FDA (Devices) · 2026-07-08
- ModerateShiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10
- ModerateCovidien Mon-a-Therm general purpose temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
Same hazard · packaging defect
See all →- HighMD Wipe Outz Numbing Tattoo Wipes Recalled for Child Poisoning Risk
CPSC · 2026-08-27
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- SevereDermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighBiopsy Forceps Recall: Sterile Packaging Breach Risk
FDA (Devices) · 2026-08-12