Recall Z-2632-2023 ยท MSD Catheter, Hemodialysis, Implanted
Covidien LP
Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
| Date | Sep 25, 2023 (initiated Aug 22, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | An URGENT: MEDICAL DEVICE RECALL notification letter was sent to customers on 8/22/23. Required Actions: 1. Immediately quarantine and discontinue use of all unused affected lots of the Palindrome" 14.5 Fr/Ch (4.8 mm) x 23 cm Chronic Catheter Kits. Please note: This recall does not include Palindrome Precision Catheter Kits. 2. Complete the online Customer Confirmation Form using the QR code located at the top of the first page of this letter or by using the link below. We request your response within 3 business days of receiving this notice. Replying promptly will confirm your receipt of thi |
| Quantity | 3050 devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, China, Czech Republic, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, Puerto Rico, Spain, Thailand, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111372 | TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)... Covidien, Aug 4, 2011 |