Palindrome SI Chronic Dialysis Catheters Recalled for Hub Leaking Risk
Covidien is recalling 2,462 units of Palindrome SI Chronic Catheters due to a potential leaking condition in the hub that may cause unanticipated fluid return during treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Although this is an FDA Class I medical device, no illnesses or injuries have been reported. The hazard is theoretical (potential leaking with unconfirmed impact), placing it in the rubric category of 'risk-of-harm products where injury has not yet been reported,' which scores 3 (High).
Plain-English summary
Covidien LLC is recalling 2,462 units of Palindrome SI Chronic Catheters, sterile, single-use devices intended for acute and chronic hemodialysis, apheresis, and infusion. The recalled units were distributed worldwide and throughout the United States.
The catheters contain a potential leaking condition in the hub component due to an inter-lumen void, which may result in unanticipated fluid return during use.
Patients and healthcare providers who have these catheters should stop using affected units and contact Covidien or their healthcare provider. Healthcare facilities should identify affected units using the product codes and serial numbers provided by the FDA.
The recalled product
- Product
- Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Manufacturer
- Covidien Llc
- Hazard
- leak
- fluid-return
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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