Palindrome Precision Chronic Dialysis Catheter Hub Leak Risk
Palindrome Precision Chronic Catheters used for dialysis may leak due to a flaw in the hub component, potentially allowing unintended fluid to escape during treatment.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall carries an FDA Class I designation, which mandates a minimum severity level of 4. Although no illnesses or injuries have been reported, the potential for fluid leakage in a critical dialysis access device poses a direct risk to patient safety during essential treatment.
Plain-English summary
Covidien LLC is recalling Palindrome Precision Chronic Catheters, sterile single-use medical devices intended for vascular access in acute and chronic hemodialysis, apheresis, and infusion therapy. The company has identified a potential leaking condition within the hub component of certain catheters due to an internal void between the lumens.
During use, this inter-lumen void may cause unanticipated fluid to return or escape from the device. This leaking condition could compromise the safety and effectiveness of treatment.
Approximately 213,589 affected units have been distributed worldwide, including throughout all U.S. states and territories, as well as internationally. Healthcare providers and patients should discontinue use of affected catheters and consult with their medical team regarding alternative vascular access options.
The recalled product
- Product
- Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
- Manufacturer
- Covidien Llc
- Hazard
- device-leak
- hub-defect
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 (20)
- Code Information organized as "Model No.
- Serial No.
- GTIN": 8888123400
- 1729700111
- 20884521012933
- 8888123400
- 1831000130
- 1904600085
- 8888133500
- 2012100128
- 20884521013060
- 8888119360P
- 2007800129
- 10884521157699
- 2034400078
- 1720000102
- 20884521157696
- 1904200103
- 1923400228
- 1932300203
Distribution
Distributed nationwide across the United States.
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