Palindrome HSI Chronic Catheter Recalled for Potential Hub Leaking
Covidien is recalling Palindrome HSI Chronic Catheters due to a potential leaking condition in the catheter hub that may cause unanticipated fluid return during dialysis. Approximately 13,526 units distributed worldwide are affected.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This recall is classified as FDA Class I by the FDA, which indicates a serious potential for adverse health consequences or death. Per the severity rubric, FDA Class I recalls are scored as Critical.
Plain-English summary
Covidien LLC is recalling the Palindrome HSI Chronic Catheter, a medical device used for hemodialysis, apheresis, and infusion. The recall affects approximately 13,526 units distributed worldwide.
The catheters contain a potential leaking condition in the hub caused by an inter-lumen void in the hub component. This may result in unanticipated fluid return during use of the device.
The affected devices include multiple model numbers and serial numbers listed in the FDA recall notice. This is an FDA Class I recall. Healthcare providers and patients should contact Covidien LLC for further information and guidance regarding replacement or return of affected units.
The recalled product
- Product
- Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Manufacturer
- Covidien Llc
- Affected units
- 13,526
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": 8888119369
- 2009300138
- 10884521012875
- 8888119369
- 1935100070
- 20884521012872
- 2026000146
- 2028200160
- 8888123409
- 2000700062
- 10884521012967
- 20884521012964
- 2001400081
- 2009400112
- 8888128459
- 2127200434
- 10884521013049
- 20884521013046
Distribution
Part of a larger recall action
This product is one of 9 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 9 products in this recall →Related recalls
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