Recall Z-1862-2015— 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 w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145064. 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 w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145064
Reason for recall
Catheters may not meet antimicrobial specification
Data sourced from openFDA. This site is unofficial and independent of the FDA.