Agency classClass IOur severity:Severe FDA (Devices)·Z-1318-2022·Announced 2022-07-13

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.

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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use."

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
Category: Medical Device — Dialysis Equipment
Hazard: leak
fluid-return
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

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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