66 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Irrigation Kit, Small, Latex, REF: 6113, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. Intended use: Kit components to be used during Intermittent Urinary Catheterizations.
FDA Recall
Terminated
·Apogee Medical·Product code KMJ·January 18, 2011
Rusch Irrigation Tray w/Piston Catalogue Number 67890 For irrigation according to institutional guidelines.
FDA Recall
Terminated
·Teleflex Medical·Product code KMJ·February 24, 2011
Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.
FDA Recall
Terminated
·Amerx Health Care Corp.·Product code KMJ·May 20, 2016
Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.
FDA Recall
Terminated
·MEDLINE IND·Product code KMJ·December 12, 2016
Rusch Irrigation Tray w/Bulb Catalogue Number 68895 For irrigation according to institutional guidelines.
FDA Recall
Terminated
·Teleflex Medical·Product code KMJ·February 24, 2011
Forteo [teriparatide (rDNA origin) injection] black starter kits containing Triad alcohol pads. The starter kits look like insulated lunch boxes and contain alcohols pads, needles, instruction guides, and freezer gel packs. Note: the kits do not contain the drug, Forteo. Intended use: Travel starter kits to hold the drug Forteo and supplies needed to deliver the subcutaneous injection.
FDA Recall
Terminated
·Eli Lilly and Company·Product code KMJ·March 17, 2011
Lubricating Jelly packaged as follows: (1) DeRoyal(R) Water Soluble Lubricant, Size: 5 Gram, Rx Only, REF 31-702, STERILE EO, Distributed by: DeRoyal - 200 DeBusk Lane, Powell, TN 37849, USA; (2) DeRoyal(R) Water Soluble Lubricant, 1 / Pack, Size: 2 oz Rx Only, REF 31-704, STERILE EO, Distributor: DeRoyal, 200 DeBusk Lane, Powell, TN 37849, USA; (3) DeRoyal(R) Lubricant, Size: 5 Gram, Rx Only, REF 31-938, STERILE EO, Distributed by: DeRoyal - 200 DeBusk Lane, Powell, TN 37849, USA Lubricating body orifices.
FDA Recall
Terminated
·Product code KMJ·February 7, 2011
Irrigation Kit, Medium, Latex, REF: 6112, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. Intended use: Kit components to be used during Intermittent Urinary Catheterizations.
FDA Recall
Terminated
·Apogee Medical·Product code KMJ·January 18, 2011
Catheter Insertion Kit, REF: 6100A, Latex Free, Sterile, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. Intended use: Kit components to be used during Intermittent Urinary Catheterizations.
FDA Recall
Terminated
·Apogee Medical·Product code KMJ·January 18, 2011
Irrigation Kit, Medium, Vinyl, REF: 6115, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. Intended use: Kit components to be used during Intermittent Urinary Catheterizations.
FDA Recall
Terminated
·Apogee Medical·Product code KMJ·January 18, 2011
Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi transparent flexible plastic bottles. Product Usage: The product is used as a patient lubricant which eases insertion of earmolds and hearing instruments such as hearing aids.
FDA Recall
Terminated
·Westone Laboratories, Inc.·Product code KMJ·July 13, 2012
Irrigation Kit, Large, Latex, REF: 6111, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. Intended use: Kit components to be used during Intermittent Urinary Catheterizations.
FDA Recall
Terminated
·Apogee Medical·Product code KMJ·January 18, 2011
Irrigation Kit, Small, Vinyl, REF: 6116, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. Intended use: Kit components to be used during Intermittent Urinary Catheterizations.
FDA Recall
Terminated
·Apogee Medical·Product code KMJ·January 18, 2011
Lubricating Jelly, Sterile, Non-staining, Made in the USA, packaged into the following size containers 5 gram tube, 2 ounce and 4 ounce tubes, 4 ounce bottle, 3 and 5 gram packets Intended use: A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. Brand names: 1. Allegiance, Distributed by: Cardinal Health, McGaw Park, IL 60085-6787, USA, Cat. LJT2. Net Wt. 2 oz., Cat. LJF3, Net Wt. 3g, Cat. LJT4, Net Wt. 4 oz., Cat. LJT5, Net Wt. 5 g; 2. Select medical products, manufactured for PSS World Medical, Inc., 4345 Southpoint Blvd., Jacksonville, FL 32216, Reorder #137, 3 g/packet, Reorder #136, 4 oz.; 3. Novaplus, Manufactured for Novation, Inc., Irving, TX 75039, Manufactured by: Triad Group, Inc., 700 West North Shore Drive, Hartland, WI 53029, Cat. No. V10-8344, Net Wt. 3 grams, Cat. No. V10-8919, Net Wt. 4 oz., Cat. No. V10-8917, Net Wt. 2 oz.; 4. Triad Group, Inc., 700 West North Shore Drive, Hartland, WI 53029, Cat. No. 10-8917, Net Wt. 2 oz, Cat. No. 10-8946, Net Wt. 5 g, Triad Plus Cat. No. 11-8344, 3 g., Cat. No. 11-8472, 5 grams, Cat. No. 10-8919, Net Wt. 4 oz, Cat. No. 10-8500, Net Wt. 4 oz; 5. IMCO, Manufactured for: Independent Medical Co-op, Inc., Daytona Beach, FL 32114. Reorder No. 8919-IMC Net Wt. 4 oz.; 6. McKesson Medi-Pak Performance, Marketed by McKesson Corporation, McKesson Surgical, Richmond, VA 23228. Reorder No. 66-8919, Net Wt. 4 oz.; 7. Henry Schein, Distributed by: Henry Schein Inc., Melville, NY 11747. 104-9637, Net Wt. 4 fl. oz.
FDA Recall
Terminated
·H & P Industries, Inc. dba Triad Group·Product code KMJ·December 23, 2010
Irrigation Kit, Large, Vinyl, REF: 6114, Apogee Medical, LLC, 90 Weathers Street, Bournesville, NC 27596. Intended use: Kit components to be used during Intermittent Urinary Catheterizations.
FDA Recall
Terminated
·Apogee Medical·Product code KMJ·January 18, 2011
Lube Jelly, 1 oz. water-base sterile lubricating jelly, a component of various Presource Custom Sterile Convenience Packs/Modules; Packaged by Cardinal Health Medical Products and Services, McGaw Park, IL 60085 U.S.A.; The affected lots of modules actually contain a 1 oz. tube of Non-Sterile Kendall Vaseline White Petroleum Jelly. Designed to assist hospitals in preparing for procedures by grouping all of the necessary components used for a procedure in one wrapper.
FDA Recall
Terminated
·Cardinal Health·Product code KMJ·February 28, 2011
Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System is intended to be used for the reconstruction of the temporomandibular joint. It is indicated for patients with one or more of the following conditions: Inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment; Recurrent fibrous and/or bony ankylosis not responsive to other modalities of treatment; Failed tissue graft; Failed alloplastic joint reconstruction; Loss of vertical mandibular height and/or occlusal relationship due to bone resorption, trauma, developmental abnormality, or pathologic lesion
FDA Enforcement
Class II
·Terminated·TMJ Solutions Inc·April 25, 2018
Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System is intended to be used for the reconstruction of the temporomandibular joint. It is indicated for patients with one or more of the following conditions: Inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment; Recurrent fibrous and/or bony ankylosis not responsive to other modalities of treatment; Failed tissue graft; Failed alloplastic joint reconstruction; Loss of vertical mandibular height and/or occlusal relationship due to bone resorption, trauma, developmental abnormality, or pathologic lesion
FDA Recall
Terminated
·TMJ Solutions Inc·Product code LZD·March 12, 2018
Skytron Infinity Series surgical light, 4 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF54, IF54EL, IF54LH and IF54S.
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007
Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Japan; Models IN19, IN19EL, IN19LH and IN19S.
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007