Recall Z-1318-2022— Covidien Llc

Name: FDA recall Z-1318-2022
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: K112477. Product: Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. 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

K112477 — PALINDROME H, SI, HSI CHRONIC CATHETERCovidien·cleared 2011-09-28

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 SI Chronic Catheter, Sterile, Single Use, Rx Only. 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.