Palindrome Precision SI Chronic Catheters Recalled for Potential Hub Leaking
Covidien recalls Palindrome Precision SI chronic dialysis catheters due to a potential leaking condition in the hub that may cause unanticipated fluid return during use.
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: The FDA classified this recall as Class I, which mandates a minimum severity score of 4 per the rubric. Although no injuries or illnesses are reported in the source text, the Class I designation indicates serious potential for patient harm due to the device defect.
Plain-English summary
Covidien Llc is recalling 2,462 units of the Palindrome Precision SI Chronic Catheter, a sterile, single-use, prescription-only device used for vascular access in acute and chronic hemodialysis, apheresis, and infusion. The recall encompasses worldwide distribution, including all US states and multiple international locations.
The FDA classified this as a Class I recall. The catheters contain a potential leaking condition in the hub component due to an inter-lumen void. This defect may result in unanticipated fluid return during use.
Patients and healthcare providers with these devices should contact Covidien for information regarding the affected units and appropriate next steps.
The recalled product
- Product
- Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
- Manufacturer
- Covidien Llc
- Hazard
- fluid-leakage
- 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": 8888119368
- 1925200090
- 20884521012841
- 8888119368
- 1933700094
- 2001400077
- 2026000056
- 8888123408
- 2009400114
- 20884521012957
- 8888128458
- 1935100068
- 20884521013039
- 8888133508
- 2026000060
- 20884521013107
- 8888145062
- 2031800153
Distribution
Distributed nationwide across the United States.
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