Agency classClass IOur severity:Severe FDA (Devices)·Z-1317-2022·Announced 2022-07-13

Palindrome H Chronic Catheters Recalled for Potential Hub Leaking

Palindrome H Chronic Catheters are being recalled due to a potential leaking condition in the catheter hub that may result in unanticipated fluid return during hemodialysis treatment. Affected units have been distributed worldwide.

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: This FDA Class I classification indicates a serious defect with significant potential for patient harm. Although no illnesses or injuries have been reported in the source, the defect in a critical medical device used in life-sustaining hemodialysis treatment warrants a Severe rating per the minimum threshold for Class I recalls.

Plain-English summary

Covidien LLC is recalling the Palindrome H Chronic Catheter, a sterile, single-use medical device used for acute and chronic hemodialysis, apheresis, and infusion treatment. The recall affects approximately 26,474 units.

The recall was initiated due to a potential leaking condition in the catheter hub caused by an inter-lumen void in the hub component. This defect may cause unanticipated fluid return during use, potentially affecting treatment safety and effectiveness.

The affected catheters have been distributed worldwide, including throughout the United States and numerous international markets. Patients using these catheters and their healthcare providers should seek further guidance from Covidien LLC regarding this recall and any necessary steps.

The recalled product

Product: Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Manufacturer: Covidien Llc
Category: Medical Device — Dialysis Catheter
Hazard: fluid-leak
device-malfunction
Affected units: 26,474

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": 8888119365
1925200097
20884521012810
8888119371
2031800117
20884521056562
8888123405
2028200168
20884521012940
2127200428
8888145043
1932200082
10884521013223
2003700042
2014900147
2023300169
2031800113
2034400185

Distribution

Distributed nationwide across the United States.

The notice also names 53 states specifically:

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.

See all 9 products in this recall →

Same manufacturer · Covidien Llc

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Same hazard · fluid leak