59 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Sterile Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020
Basic Setup Pack, part number AMS1787(A Basic Setup Pack, part number AMS6519
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Sterile Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020
XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids. XGAUZE is packed in a pre-formed sterile barrier system (pouch sealed on three sides); one side is a PET/foil/PE film, and the other side is a PET/aluminum oxide/PE film. Packages are vacuum sealed and terminally sterilized via gamma radiation.
FDA Enforcement
Class II
·Terminated·Revmedx Inc·September 23, 2015
Sterile Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020
Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. Part Number: 823087
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code JXG·December 14, 2020
Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting cerebrospinal fluid (CSF) Part Number: 823073
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code JXG·December 14, 2020
Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830
FDA Recall
Terminated
·Product code ITJ·March 6, 2020
BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature. Item Numbers H96560M0125711 H96560M0133541 H96560M0354721 H96560M0367081 H96560M05019121 H96560M05019131 H96560M1220291 H96560M1303161 H96560M1303181 H96560M1318211 H96560M1408911 H96560M1429481 H96560M1803431 H96560M18157131 H96560M2208531 H96560M2208541 H96560M2500981 H96560M611025111 H96560M611052811 H96560M611056011 H96560M611095811 H965PKM1387818S1 H965PKM1404211S1 H965PKM1635214S1 H965PKM220533S1 H965PKM220853S1 H965PKM220855S1 H965PKM61095322S1 H965PKM61102511S1 Cat. No. 60M012571 60M013354 60M035472 60M036708 60M0501912 60M0501913 60M122029 60M130316 60M130318 60M131821 60M140891 60M142948 60M180343 60M1815713 60M220853 60M220854 60M250098 60M61102511 60M61105281 60M61105601 60M61109581 PKM1387818S PKM1404211S PKM1635214S PKM220533S PKM220853S PKM220855S PKM61095322S PKM61102511S
FDA Enforcement
Class II
·Terminated·Angiodynamics, Inc.·June 24, 2020
KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)
FDA Recall
Terminated
·Microbiologics Inc·Product code JTR·December 16, 2020
Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
FDA Recall
Terminated
·Remel Inc·Product code JSI·December 10, 2020
COHERENCE Oncologist, Model Nos. 07333680 & 07351898
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·January 16, 2020
BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature. Item Numbers H965460151 H965460161 H965460161-NP H965460171 H965460181 H965460221 H965460231 H965460241 H965460251 H965460261 H965460271 H965460281 H965460291 H965464601 H965464701 H965464701-NP H965464801 H965464901 Cat. No. 46-015 46-016 46-016-NP 46-017 46-018 46-022 46-023 46-024 46-025 46-026 46-027 46-028 46-029 46-460 46-470 46-480 46-490
FDA Enforcement
Class II
·Terminated·Angiodynamics, Inc.·June 24, 2020
Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport Medium, Ref: VCTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450499917, 50 Units - (01)10884450499914, 200 units - (01)20884450499911
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code JSM·September 16, 2020
MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code KXG·September 16, 2020
CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector
FDA Recall
Terminated
·Avanos Medical, Inc.·Product code KNT·October 16, 2020
Merit Medical Cultura Collection and Transport System, Ref CFTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450492123, 50 Units - (01)10884450492120, 200 units - (01)20884450492127
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code JSM·September 16, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)07613327012460(17)
FDA Recall
Terminated
·Howmedica Osteonics Corp.·Product code LPH·April 16, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17)
FDA Recall
Terminated
·Howmedica Osteonics Corp.·Product code LPH·April 16, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 left, Sterile, Catalog # 504-02-68F-L, UDI (01)07613327012521(17)
FDA Recall
Terminated
·Howmedica Osteonics Corp.·Product code LPH·April 16, 2020