197 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Violet Ink sterilization indicators Violet Ink (Class 6) and Violet Ink (Bowie Dick). Product numbers: CI 144, BD 115, PL 315, PL319, PL232, PL236, PL237, PL 238.
FDA Recall
Terminated
·Steritec Products Mfc. Co., Inc.·Product code JOJ·July 15, 2009
Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
FDA Enforcement
Class I
·Terminated·Cook Inc.·August 12, 2015
Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland
FDA Enforcement
Class II
·Terminated·Insulet Corporation·March 17, 2021
Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.
FDA Recall
Terminated
·Viscot Medical LLC·Product code FZZ·August 22, 2012
Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code FRN·April 13, 2004
Colleague 3 Triple Channel Volumetric Infusion Pumps, product code 2M8153 and 2M8153K (United Kingdom); Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; monochrome display screen
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code FRN·April 13, 2004
Colleague CX Single Channel Volumetric Infusion Pumps, product code 2M8161; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code FRN·April 13, 2004
Colleague Single Channel Volumetric Infusion Pumps, product code 2M8151and 2M8151K (United Kingdom); Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; monochrome display screen
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code FRN·April 13, 2004
Aspen Surgical, Corneal Marking Pad, Gentian Violet Ink, REF 40490, Rx only, Sterile. For use in ophthalmic surgery.
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code HMR·December 23, 2010
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840
FDA Recall
Terminated
·OMNIlife science Inc.·Product code LPH·July 23, 2019
Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
FDA Recall
Terminated
·Steris Corporation·Product code FRG·June 15, 2017
Vis-U-All High Temp 16"x16" Self Seal Pouch 100 pouches per box; 6 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
FDA Recall
Terminated
·Steris Corporation·Product code FRG·June 15, 2017
Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
FDA Recall
Terminated
·Steris Corporation·Product code FRG·June 15, 2017
Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
FDA Recall
Terminated
·Steris Corporation·Product code FRG·June 15, 2017
Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
FDA Recall
Terminated
·Steris Corporation·Product code FRG·June 15, 2017
Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
FDA Recall
Terminated
·Steris Corporation·Product code FRG·June 15, 2017
OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836 Product Usage: The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cups are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2, Apex K2 mid length or Apex K1 Hip in total hip replacement procedures. The acetabular cup inserts are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis Rheumatoid arthritis Correction of functional deformity Congenital dislocation Revision procedures where other treatments or devices have failed
FDA Recall
Terminated
·OMNIlife science Inc.·Product code LPH·May 18, 2018
Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box; 9 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
FDA Recall
Terminated
·Steris Corporation·Product code FRG·June 15, 2017
Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
FDA Recall
Terminated
·Steris Corporation·Product code FRG·June 15, 2017
Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
FDA Recall
Terminated
·Steris Corporation·Product code FRG·June 15, 2017