6 results
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31ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Orajel toddler EXTRA GENTLE Yellow Manual Toothbrush, Model 7531. Made in China --- The toothbrush is to be replaced every 3 months. --- Firm on label: DEL PHARMACEUTICALS, INC. a subsidiary of Del Laboratories, Inc. Uniondale, NY 11553
FDA Recall
Terminated
·Del Laboratories Inc.·Product code EFW·June 9, 2005
Brand REMOVE Universal Adhesive Remover Wipe - Pouch Label and 50 count box Label: ***smith&nephew***#403100*** REMOVE Universal Adhesive Remover Wipes Gently removes tapes and adhesives Reduces risk of irritation and skin stripping Contains Aloe***1 wipe and 50 wipes*** For external use only. Avoid eyes - Use with adequate ventilation. Keep out of reach of children. INGREDIENTS: Dipropylene Glycol Methyl Ether, C10-11 Isoparaffin, Aloe Extract, Benzyl Alcohol, Fragrance. ------------------- Brand: Universal Adhesive Remover Wipes - Carton Label: ***smith& nephew Universal Adhesive Remover Wipes ***Quantity 20 Cartons of 50 Code #403100***. Product Usage: Adhesive removers gently clean all types of adhesive residue from the skin, including hydrocolloid-based, acrylic-based and ruber-based adhesives.
FDA Recall
Terminated
·Smith & Nephew Inc.·Product code KOX·April 4, 2011
Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.
FDA Recall
Terminated
·Vycor Medical, Inc.·Product code GZT·August 21, 2012
Product is labeled in part - Pouch label: "***ORTHOFIX***Manufactured By: Nanotherapeutics, Inc. 13859 Progress Blvd, Suite 300 Alachua, FL 32615 (386) 462-9663***Description: Origen***DBM Paste***Size***REF:***ID***Expiration***STERILE R***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***Rx Only***" Product is labeled in part - Carton label: "***Origen DBM with Bioactive Glass***REF***ID***Expiration***Manufactured for Blackstone Medical, Inc by: Nanotherapeutics, Inc. 13859 Progress Blvd. suite 300 Alachua, FL 32615***Distributed By: Orthofix Inc 1720 Bray Central Drive McKinney, TX 75069***Rx Only***ONE EACH***" Origen DBM with Bioactive Glass Catalog #: 22-2002 (2cc size) 22-2005 (5cc size) 22-2010 (10cc size) "Bone void filler comprised of a gelatin carrier, bioactive glass (45s5), and human demineralized bone matrix (DBM) intended for transplantation." Indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (e.g. the extremities and pelvis).
FDA Recall
Terminated
·Nanotherapeutics, Inc·Product code MQV·March 10, 2011
Product is labeled in part - Pouch label: "***NanoFUSE***DBM***Manufactured and Distributed By: Nanotherapeutics, Inc. 13859 Progress Blvd, Suite 300 Alachua, FL 32615 (386) 462-9663***Description: nanoFUSE DBM***Size***Order No.:***ID***Expiration***STERILE R***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***Rx Only***nanotherapeutics***" Product is labeled in part - Carton label: "***nanoFUSE DBM***Order No:***ID***Expiration***nanotherapeutics***Manufactured and Distributed By: Nanotherapeutics, Inc. 13859 Progress Blvd. Suite 300 Alachua, FL 32615***Rx Only***ONE EACH***" NanoFUSE DBM Catalog #: NAN109-02 (2cc size) NAN109-05 (5cc size) NAN109-10(10cc size) "Bone void filler comprised of a gelatin carrier, bioactive glass (45s5), and human demineralized bone matrix (DBM) intended for transplantation." Indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (e.g. the extremities and pelvis).
FDA Recall
Terminated
·Nanotherapeutics, Inc·Product code MQV·March 10, 2011
Brand: UNI-SOLVE Adhesive Remover Wipe Pouch, 50 Count Box Label ***smith&nephew***#402300*** UNI-SOLVE Adhesive Remover Wipe Effectively removes tapes and adhesives Reduces irritation and risk of skin stripping Easy to use, no mess Gentle***1 wipe*** For external use only. Avoid eyes - Use with adequate ventilation. Keep out of reach of children. INGREDIENTS: C10-11 Isoparaffin, Isopropyl Alcohol, Dipropylene Glycol Methyl Ether, Aloe Extract, Fragrance. Brand UNI-SOLVE Adhesive Remover Wipes - Carton Label: smith&nephew Adhesive Remover Wipes ***UNI-SOLVE***Quantity 20 Cartons of 50 Code #402300*** -------------------- Brand: REMOVE CE Adhesive Remover Wipe - Pouch Label and 50 Count Box Label: ***smith&Nephew***#59403125***REMOVE***US Patent no. 5336207***CE***. Formulation F-57 S&N Product Code 402300 UNI-SOLVE Adhesive Remover Wipes. Formulation F-57 S&N Product Code 59403125 REMOVE CE Adhesive Remover. Product Usage: Reduce adhesive trauma to the skin by thoroughly dissolving dressing tape and appliance adhesives. .
FDA Recall
Terminated
·Smith & Nephew Inc.·Product code KOX·April 4, 2011