Palindrome Chronic Catheter Kit Recalled for Packaging Defect
Covidien LLC is recalling 280 units of Palindrome Chronic Catheter Kits because they were incorrectly packaged with a 90-degree bend at the distal tip.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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, and the hazard is a packaging defect (bent tip) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 280 units of the Palindrome Chronic Catheter Kit Symmetrical Tip, manufactured by Covidien LLC. The specific item number is 8888145042, and the affected lots are 1503500094, 1431900098, and 1435800009. The recall was initiated because the catheters were 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 in the United States (nationwide), Canada, Belgium, Chile, Panama, Denmark, France, Germany, the Netherlands, Spain, Switzerland, and the United Kingdom.
Healthcare facilities and consumers should stop using the affected catheters and contact the manufacturer for further instructions or a replacement.
The recalled product
- Product
- Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by…
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 280
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)
- Lot Numbers: 1503500094
- 1431900098
- 1435800009
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
- ModerateCovidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateShiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10
Same hazard · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- HighPalindrome Precision SI Chronic Catheter Kit Recall for Antimicrobial Failure
FDA (Devices) · 2015-07-08
- SeverePalindrome Precision SI Chronic Catheter Kit Recalled for Antimicrobial Failure
FDA (Devices) · 2015-07-08
- HighPalindrome Precision SI Chronic Catheter Kit Recall for Antimicrobial Defects
FDA (Devices) · 2015-07-08
- HighPalindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
FDA (Devices) · 2015-07-08
- HighPalindrome Precision HSI Chronic Catheter Kit Recalled for Antimicrobial Defect
FDA (Devices) · 2015-07-08
- HighCovidien Recalls Palindrome Precision SI Chronic Catheter Kits
FDA (Devices) · 2015-07-08