Palindrome H Chronic Catheters Recalled for Potential Hub Leaking
Palindrome H Chronic Catheters are being recalled due to a potential leaking condition in the catheter hub that may result in unanticipated fluid return during hemodialysis treatment. Affected units have been distributed worldwide.
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 FDA Class I classification indicates a serious defect with significant potential for patient harm. Although no illnesses or injuries have been reported in the source, the defect in a critical medical device used in life-sustaining hemodialysis treatment warrants a Severe rating per the minimum threshold for Class I recalls.
Plain-English summary
Covidien LLC is recalling the Palindrome H Chronic Catheter, a sterile, single-use medical device used for acute and chronic hemodialysis, apheresis, and infusion treatment. The recall affects approximately 26,474 units.
The recall was initiated due to a potential leaking condition in the catheter hub caused by an inter-lumen void in the hub component. This defect may cause unanticipated fluid return during use, potentially affecting treatment safety and effectiveness.
The affected catheters have been distributed worldwide, including throughout the United States and numerous international markets. Patients using these catheters and their healthcare providers should seek further guidance from Covidien LLC regarding this recall and any necessary steps.
The recalled product
- Product
- Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Manufacturer
- Covidien Llc
- Hazard
- fluid-leak
- device-malfunction
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": 8888119365
- 1925200097
- 20884521012810
- 8888119371
- 2031800117
- 20884521056562
- 8888123405
- 2028200168
- 20884521012940
- 2127200428
- 8888145043
- 1932200082
- 10884521013223
- 2003700042
- 2014900147
- 2023300169
- 2031800113
- 2034400185
Distribution
Distributed nationwide across the United States.
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