5 results
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29ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
FDA Recall
Terminated
·CryoLife, Inc.·Product code MUQ·May 19, 2017
Arctic Sun ArcticGel Pads - Medium, Product Code 317-07
FDA Recall
Open, Classified
·C.R. Bard, Inc.·Product code DWJ·June 2, 2017
LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains a desiccant to prevent adverse moisture accumulation. A LYFO Disk" catalog number ends in L.
FDA Recall
Terminated
·Microbiologics Inc·Product code JTR·March 2, 2017
The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
FDA Recall
Terminated
·OriGen Biomedical, Inc.·Product code DWF·August 2, 2017
KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. A KWIK-STIK" catalog number ending in P is a duopak and contains two KWIKSTIK" sticks.
FDA Recall
Terminated
·Microbiologics Inc·Product code JTR·March 2, 2017