Recall Z-1313-2022— Covidien Llc

Name: FDA recall Z-1313-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-08

Class I · Ongoing

Class I FDA medical device recall by Covidien Llc, initiated 2022-06-08. It names one FDA 510(k) clearance: K123196. Product: Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.. Reason: 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..

Recalling firm: Covidien Llc
Classification: Class I
Status: Ongoing
Initiated: 2022-06-08
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K123196 — PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATHCovidien·cleared 2013-01-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.