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Sources: EU EUDAMED, US FDA
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FDA Recall
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Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
FDA Recall
Open, Classified
·The Biomed Guys·Product code FRN·March 25, 2021
CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323
FDA Recall
Terminated
·Richard Wolf GmbH Pforzheimer Str. 32 Knittlingen Germany·Product code FJL·June 25, 2021
RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It provides a convenient method of performing periodic QC checks to verify correct system measurement.
FDA Recall
Terminated
·Medline Industries Inc·Product code JPK·January 25, 2021
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
FDA Recall
Open, Classified
·OPTI Medical Systems, Inc·Product code QJR·June 25, 2021
RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)
FDA Recall
Open, Classified
·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·March 25, 2021
Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.
FDA Recall
Terminated
·Mercedes Medical, Inc.·Product code QBD·June 10, 2021
Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw blades.
FDA Recall
Terminated
·DeRoyal Industries Inc·Product code LRO·January 25, 2021
Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs including sternum saw blades.
FDA Recall
Terminated
·DeRoyal Industries Inc·Product code LRO·January 25, 2021
Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.
FDA Recall
Terminated
·Mercedes Medical, Inc.·Product code QBD·June 10, 2021
Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.
FDA Recall
Open, Classified
·Smith & Nephew, Inc.·Product code HRS·October 25, 2021
CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16 Custom surgical procedure packs including sternum saw blades.
FDA Recall
Terminated
·DeRoyal Industries Inc·Product code LRO·January 25, 2021
MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
FDA Recall
Terminated
·Aesculap Implant Systems LLC·Product code HXX·October 25, 2021
BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with FilmArray systems.
FDA Recall
Terminated
·BioFire Diagnostics, LLC·Product code PEN·January 26, 2021
Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems. Part No: RFIT-ASY-0126 / UDI: 00815381020086 Part No: RFIT-ASY-0127 / UDI: 00815381020093 IVD, Rx Only
FDA Recall
Terminated
·BioFire Diagnostics, LLC·Product code PEN·January 26, 2021
The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code NJL·February 22, 2021
The ATTUNE Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code NJL·February 22, 2021
The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of silicone and consists of 4 main components: a pump, two cylinders, a fluid reservoir and kink-resistant tubing that is used to connect the pump to the cylinders and fluid reservoir. By pumping the fluid within the system from the reservoir via the pump and into the cylinders, the product creates an erection in men who have chronic, organic, erectile dysfunction. Part Number: 720185-01, 72404156
FDA Recall
Terminated
·Boston Scientific Corporation·Product code JCW·March 26, 2021
Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic Name: Hip Prosthesis). The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell; acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW; and ceramic and CoCrMo modular heads. The ceramic and CoCrMo modular heads are compatible with Corin titanium femoral stems. The Trinity Biolox Ceramic heads are packaged in a double peel pouch configuration.
FDA Recall
Terminated
·Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code MEH·January 25, 2021
VITROS Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics, INc.·Product code N/A·March 26, 2021
Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic Name: Hip Prosthesis). The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell; acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW; and ceramic and CoCrMo modular heads. The ceramic and CoCrMo modular heads are compatible with Corin titanium femoral stems. The Trinity Biolox Ceramic heads are packaged in a double peel pouch configuration.
FDA Recall
Terminated
·Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code MEH·January 25, 2021