Recall Z-1447-2020— Covidien Llc
Class II · Terminated
Class II FDA medical device recall by Covidien Llc, initiated 2020-02-10, terminated 2024-04-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Europe, Middle East, and Africa) only. No US distribution. Kits are manufactured in The Netherlands. Item codes BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT02 LAR28PLN MGBGLOCX1 SGGLOCX1 HEMICX1 LAPWL STOM25PL TGGLOCX1 TIROIDEKIT UROCYSPL VAGHCJ VATSZD2 VGYN VMED VMED3 ZGVATS1. Reason: Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection..
- Recalling firm
- Covidien Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-02-10
- Terminated
- 2024-04-26
- Firm location
- Mansfield, MA, United States
Product description
Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Europe, Middle East, and Africa) only. No US distribution. Kits are manufactured in The Netherlands. Item codes BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT02 LAR28PLN MGBGLOCX1 SGGLOCX1 HEMICX1 LAPWL STOM25PL TGGLOCX1 TIROIDEKIT UROCYSPL VAGHCJ VATSZD2 VGYN VMED VMED3 ZGVATS1
Reason for recall
Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.
Data sourced from openFDA. This site is unofficial and independent of the FDA.