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Crédits
Manufacturers
Wilson-Cook Medical Inc
Adresse du fabricant
Wilson-Cook Medical Inc, 5951 Grassy Creek Blvd, Winston Salem NC 27105-1206
Source
USFDA
13 Events
Rappel de Device Recall Zilver Expandable Metal Biliary Stent System.
Rappel de Device Recall Howell D.A.S.H. II Direct Access System
Rappel de Device Recall OasisOne Action Stent Introduction System with ST2 Soehendra Tannenbaum Biliary Stent
Rappel de Device Recall Four Shooter Saeed MultiBand Ligator
Rappel de Nasal Jejunal Feeding Tube, Tube Diameter: 10 FR. Tube Length: 240CM., Disposable ¿ Single Use Only, Rx Only***COOK¿ Wilson ¿ Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
Rappel de Esophageal Z-Stent¿ Fully Coated or Uncoated Flanges, Endoprosthesis Systems with the Z Speed Introducer, Disposable ¿ Single Use Only, Rx Only, Sterile EO, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
Rappel de CLBS-7-12 * Cotton-Leung Biliary Stent Set * Stent Diameter: 7 Fr. * Length (Between Flaps): 12 CM. * Standard Wire Guide: .035''/480 CM. * Pushing Catheter: 7 FR. * Disposable ¿ Single Use Only- Rx Only * Wilson-Cook Medical, GI Endoscopy * 4900 Bethania Station Road * Winston-Salem, NC 27105.
Rappel de Low Profile Gatrostomy - Contents include: Passport & Obturator * Disposable ¿ Single Use Only * Wilson-Cook Medical, GI Endoscopy * 4900 Bethania Station Road * Winston-Salem, NC 27105.
Rappel de AcuSnare
Rappel de Biliary Stent Introducer Set
Rappel de ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew
Rappel de BCP-7A, Quick Silver Bipolar Coagulation Probe, For use w/dual Plug Bipolar Generators
Rappel de Fusion OMNI- GT * DOME TIP: ERCP Catheter: 6.0 FR./200 CM. 8 Minimum Accessory Channel: 4.2 MM * Disposable ¿ Single Use Only * Compatible Wire Guide: .035'' * Rx Only * Wilson-Cook Medical * GI Endoscope * 4900 Betharine Station * Winston-Salem, NC 27105
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13 dispositifs dans la base de données
Device Recall Zilver Expandable Metal Biliary Stent System.
Modèle / numéro de série
Catalog number: ZILBS-10-4, ZILBS-6-4, ZILBS-8-4, ZILBS-10-6, ZILBS-6-6, ZILBS-8-6, ZILBS-10-8, ZILBS-6-8, ZILBS-8-8, Lot number: 1616783, 1616787, 1622794, 1622798, 1622802, 166958, 1622966, 162970, 162993, 1623007, 1623016, 1626424, 1631805, 1616784, 1616788, 1622795, 1622799, 1622803, 1622959, 1622803, 1622959, 1622963, 1622967, 1622982, 1622994, 1623008, 1623017, 1631388, 1633707, 1616785, 1616789, 1622796, 1622800, 1622804, 1622960, 1622964, 1622968, 1622985, 1623001, 1623009, 1623018, 1631803, 1634239, 1616786, 1616790, 1622797, 1622801, 1622956, 1622961, 1622965, 1622969, 1622986, 1623002, 1623015, 1626423, 1631804, 1635626.
Classification du dispositif
Gastroenterology-Urology Devices
Classe de dispositif
2
Dispositif implanté ?
Yes
Distribution
The device was distributed nationwide, Ireland and Jordan.
Description du dispositif
ZILBS-8-6, ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM, Stent Diameter: 8 MM. Stent Length: 6 CM., Accepts .035'' Wire Guide, Introduction system: 7 FR., Minimum Scope Channel: 2.8 MM., Disposable-Single Use Only, Rx Only, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
Device Recall Howell D.A.S.H. II Direct Access System
Modèle / numéro de série
Reorder Number: DASH-35-480, Lot Number: W1815864
Classification du dispositif
Gastroenterology-Urology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Units were distributed to medical facilities in AZ, CA, MN, NJ, NY, OH and Egypt.
Description du dispositif
Howell D.A.S.H. II Access System, Wire Guided Sphincterotome
Device Recall OasisOne Action Stent Introduction System with ST2 Soehendra Tannenbaum Biliary Stent
Modèle / numéro de série
Reorder number: OATS-11.5-5, Lot number: 1637695, 1651258, 1711817, 1713997, W1730838, W1752589, W1817595; Reorder number: OATS-11.5-7, Lot number: 1637696, 1651259, 1711818, 1711819, W1730839, W1738240; Reorder number: OATS-11.5-9, Lot number: 1637697, 1651260, 1702218, 1711820, 1711821, W1738241; Reorder number: OATS-11.5-12, Lot number: 1637694, 1651257, 1683866, W1730837, W1738238, W1752587; Reorder number: OATS-11.5-15 Lot number: 1692178, 1692179, 1711816, W1738239, W1752588
Classification du dispositif
Gastroenterology-Urology Devices
Classe de dispositif
2
Dispositif implanté ?
Yes
Distribution
Product was shipped to one distributor in Japan.
Description du dispositif
Oasis-One Action Stent Introduction System with ST-2 Soehendra Tannenbaum Biliary Stent, (11.5 French size only), Guiding Catheter: 6 FR, Minimum Accessory Channel Size: 3.7mm, Wire Guide Sold Separately, Disposable ¿ Single Use Only, Quality System ISO 9001 Certified, Rx Only, Wilson-Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
Device Recall Four Shooter Saeed MultiBand Ligator
Modèle / numéro de série
Reorder/Catalog number MBL-4-XL, Lot W1842922
Classification du dispositif
Gastroenterology-Urology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
All units were shipped to one medical facility in CA
Description du dispositif
Four Shooter Saeed Multi-Band Ligator
Nasal Jejunal Feeding Tube, Tube Diameter: 10 FR. Tube Length: 240CM., Disposable ¿ Single Use On...
Modèle / numéro de série
Reorder/Catalog Number: NJFT-1-ML, Lot #1803299, Expiration Date: 09-2008
Classification du dispositif
Gastroenterology-Urology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
NC, Ireland & Poland
Description du dispositif
Nasal Jejunal Feeding Tube, Tube Diameter: 10 FR. Tube Length: 240CM., Disposable ¿ Single Use Only, Rx Only***COOK¿ Wilson ¿ Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
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Wilson-Cook Medical Inc
Société-mère du fabricant (2017)
Cook Group Incorporated
Source
NZMMDSA
Wilson-Cook Medical Inc
Adresse du fabricant
Wilson-Cook Medical Inc, 4900 Bethania Station Rd, & 5951 Grassy Creek Blvd., Winston-Salem NC 27105
Source
USFDA
Cook Endoscopy/Wilson-Cook Medical Inc
Société-mère du fabricant (2017)
Cook Group Incorporated
Source
VNSAWH
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