Recall Z-1850-2015— Covidien LLC
Class II · Terminated
Class II FDA medical device recall by Covidien LLC, initiated 2015-04-23, terminated 2017-07-26. It names 2 FDA 510(k) clearances: K112477, K060972. Product: Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion.. Reason: Catheters may not meet antimicrobial specification.
- Recalling firm
- Covidien LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-23
- Terminated
- 2017-07-26
- Firm location
- North Haven, CT, United States
510(k) clearances named in this recall
2 on FDA's record- K112477 — PALINDROME H, SI, HSI CHRONIC CATHETER
- K060972 — KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY)
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 Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion.
Reason for recall
Catheters may not meet antimicrobial specification
Data sourced from openFDA. This site is unofficial and independent of the FDA.