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Sources: EU EUDAMED, US FDA
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Surgivac Wound Drainage Device, 400 ml Surgivac 1/8" MP Sil w/trocar, 3,2mm, 10Fr, Si, 107cm, medium, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-5340-000-05 and 00-5340-000-10.
FDA Recall
Terminated
·Zimmer Inc.·Product code GCY·January 29, 2008
Surgivac Wound Drainage Device, 400 ml Surgivac 1/4" PVC w/trocar, 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-5390-040-10.
FDA Recall
Terminated
·Zimmer Inc.·Product code GCY·January 29, 2008
Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml INF. CNTRL. Kit w/ 1/4" Drain, 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2550-004-10.
FDA Recall
Terminated
·Zimmer Inc.·Product code GCY·January 29, 2008
Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850***DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com***." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04***Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USA***MediMark Europe BP2332 F-38033 Grenoble Cedex 2. France***LOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN***" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.
FDA Recall
Terminated
·Biomet Microfixation, Inc.·Product code ECI·August 18, 2011
Sarns Flexible Weighted Sucker in CUSTOM X-COATED PERFUSION PACK, catalog number 73013-01, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo Cardiovascular Systems, Ashland, MA. The Flexible Intracardiac Sucker and Weighted Flexible Sucker are indicated for stationary use to remove excess fluid from the surgical field.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code GCY·February 25, 2011
1/8 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code GCY·March 26, 2015
9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Accessories to Medpor Implants
FDA Recall
Terminated
·Stryker Leibinger GmbH & Co. KG Botzinger Strasse 41 Freiburg Germany·Product code GCY·January 3, 2017
Jackson-Pratt Silicone Flat Drain, 7mm Full W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
FDA Recall
Terminated
·Cardinal Health 200, LLC·Product code GCY·April 21, 2017