Palindrome Chronic Catheter recalled due to potential hub leakage
Covidien is recalling Palindrome Chronic Catheters due to a potential leaking condition in the hub that may cause unexpected 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: FDA Class I classification establishes a minimum severity of 4 per the rubric. No deaths or serious injuries have been reported, so the score does not rise to 5. The potential for unanticipated fluid return during use of a critical dialysis device justifies the Severe rating.
Plain-English summary
Covidien is recalling the Palindrome Chronic Catheter, a sterile, single-use medical device intended for vascular access for acute and chronic hemodialysis, apheresis, and infusion. The recall affects 576,018 units with worldwide distribution, including all US states.
The recall is due to a potential leaking condition within the hub component of specific catheter lots. An inter-lumen void in the hub may result in unanticipated fluid return during use.
Healthcare facilities should check whether they have affected lots in inventory and review the specific model and serial numbers listed with the FDA. Patients currently using affected catheters should consult their healthcare provider regarding their specific catheter lot.
The recalled product
- Product
- Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
- Manufacturer
- Covidien Llc
- Hazard
- fluid-leak
- catheter-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": 8888119360
- 1916500132
- 20884521012803
- 8888119364
- 1831000099
- 20884521056555
- 1832300114
- 2019500276
- 2106900226
- 8888123404
- 1912600108
- 20884521056586
- 1934400172
- 2012100136
- 2017500130
- 2034400075
- 2104600236
- 2125800094
Distribution
Distributed nationwide across the United States.
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