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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 2,462
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
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.
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