Recall Z-2632-2023— Covidien LP

Name: FDA recall Z-2632-2023
Creator: U.S. Food and Drug Administration
Published: 2023-08-22

Class II · Ongoing

Class II FDA medical device recall by Covidien LP, initiated 2023-08-22. It names one FDA 510(k) clearance: K111372. Product: Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm. Reason: Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable based upon the correct labeling on the catheter body..

Recalling firm: Covidien LP
Classification: Class II
Status: Ongoing
Initiated: 2023-08-22
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K111372 — TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)...Covidien·cleared 2011-08-04

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 Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm

Reason for recall

Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable based upon the correct labeling on the catheter body.

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