Recall Z-1902-2015— Covidien LLC
Class II · Terminated
Class II FDA medical device recall by Covidien LLC, initiated 2015-04-23, terminated 2017-07-26. It names 3 FDA 510(k) clearances: K123196, K112477, K062671. Product: Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050P. 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
3 on FDA's record- K123196 — PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH
- K112477 — PALINDROME H, SI, HSI CHRONIC CATHETER
- K062671 — 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE)
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 Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050P
Reason for recall
Catheters may not meet antimicrobial specification
Data sourced from openFDA. This site is unofficial and independent of the FDA.