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Sources: EU EUDAMED, US FDA
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FDA Recall
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Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are included in recall. Part Number MCA Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·March 29, 2012
Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·March 29, 2012
Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138; 2) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. P180011, UPC 810018097523; 3) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. 180020ST, UPC 840368511998; 4) SOL-M 3ml Slip Tip Syringe w/o Needle, Model No. P180003ST, UPC 810018097493; 5) SOL-M 5ml Slip Tip Syringe w/o Needle, Model No. P180005ST, UPC 810018097462; 6) SOL-M 10ml Slip Tip Syringe w/o Needle, Model No. P180010ST, UPC 810018097646; 7) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. P180020ST, UPC 810018098636; 8) SOL-M 30ml Slip Tip Syringe w/o Needle, Model No. P180030ST, UPC 810062435333; 9) SOL-M 60ml Slip Tip Syringe w/o Needle, Model No. P180060ST, UPC 810062435340; 10) SOL-M 1ml Slip Tip Syringe Sterile Convenience Tray, Model No. P180011T, UPC 810018098957
FDA Recall
Open, Classified
·Sol-Millennium Medical Inc.·Product code FMF·May 9, 2024