Palindrome Precision H Chronic Catheter Recalled for Potential Hub Leakage
Covidien is recalling certain Palindrome Precision H Chronic Catheters because the hub may leak, causing unexpected fluid to flow back during use. This FDA Class I recall affects 26,675 units distributed globally.
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: FDA Class I recalls require a minimum severity score of 4 per the rubric. This defect affects a critical vascular access device with potential for serious complications if fluid leakage occurs during use, though no illnesses or injuries have been reported to date.
Plain-English summary
Covidien is recalling specific lots of Palindrome Precision H Chronic Catheters, sterile, single-use medical devices used to provide vascular access for hemodialysis, apheresis, and infusion therapy. The recall was initiated because of a potential leaking condition in the catheter hub.
The defect is caused by an internal gap in the hub component of affected catheters. This gap may allow fluid to return unexpectedly during use, potentially compromising the device's safe operation.
The recall affects 26,675 units distributed worldwide. Affected catheters were delivered to facilities and patients throughout the United States, U.S. territories, and more than 80 countries. The FDA has documented specific serial numbers and model codes identifying the affected products.
The recalled product
- Product
- Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
- Manufacturer
- Covidien Llc
- Affected units
- 26,675
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": 8888119365P
- 2119400168
- 10884521157712
- 8888119365P
- 1923400245
- 20884521157719
- 1923400268
- 1935100114
- 2002100145
- 2002900148
- 2020400090
- 2023300173
- 2026000162
- 2031800126
- 2034400186
- 2104600103
- 2104600233
- 2108100057
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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