ClearanceBrief
Recall Z-0272-2020 ยท FMH Container, Specimen, Sterile

Thermo Fisher Scientific (Monterrey)

Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case Catalog number: CHB13904

DateJul 18, 2019
StatusTerminated
ReasonCardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial
Root causeEquipment maintenance
Action1. Please notify to any organizations that have received affected product. 2. If you have any affected product please contact Technical Support Team regarding free-of-charge product replacement. Technical Support: Phone - +1-800-625-4327 Email - technicalsupport@thermofisher.com
Quantity2,979,600 each
DistributionOH
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.