Wilson-Cook Medical Inc Recalls
Showing 1-17 of 17 recalls
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
Misbranded; The catheter size listed on the product label is 6 French, which is inaccurate. The catheter size is more accurately described as 7 French.
Consignees were notified by letter on/about 11/04/2005.
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.
The reorder number listed on the product label is inaccurate.
Consignees were notified by email/fax on 06/17/2005.
ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew Right Device: Flexible TI Knot Device: External Accessory Channel: 6mm./75 cm.; * Suture Quickload Units (2); TI Knot Quickload Units (2) * Disposable Single Use Only * Manufactured by: LSI Solutions * Sterile/EO * Rx Only * Wilson-Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
The expiration date listed on the product label is greater than the vendor recommended expiration date.
Consignees were notified by certified mail on 04/01/2005.
Spiral Z Expandable Metal Biliary Stent
The inner catheter of the introducer system may break after stent deployment.
Initially the firm conducted a Market Withdrawal on January 8, 2002. Subsequently the firm initiated a recall, notifying consignees via letter on 8/8/2003. A Customer Response Form was attached.
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
Label contains the 'Sterile EO' symbol, however the device is provided non-sterile.
Consignees were notified by visit by personal company representative to the user facility on January 30, 2003.
Brodmerkel Colon Decompression Set, CDSB-10, Catheter Diameter: 10 Fr. Catheter Length: 350 cm. Sideports: 10, Standard wire Guide: .035''/480 cm. Disposable Single use only, Rx Only. Cook, Wilson-Cook Medicl GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
Product may be packaged with an incorrect instructions for use (IFU) booklet.
Recall notification was sent via email to Wilson-Cook, sales representatives on 10/08/2003 for personal delivery to the affected accounts. Consignees were advised to quarantine and return all affected product via Federal Express (using Wilson-Cook Medical account) to the recalling firm. A verification form was included at the bottom portion of the notice to be returned with the affected product or faxed to Wilson-Cook. Replacement product or account credit will be provided upon receipt of any affected devices.
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
The nasal transfer tube may be missing from the package of the affected lot.
For the Domestic account, a recall letter was hand delivered by a Wilson-Cook representative on 5/26/2004. A letter was delivered via fax to International Distributors on 5/26/2004.
Four Shooter Saeed Multi-Band Ligator
Product label lacks the symbols specifying the meaning of the manufacturing and expiration date.
Consignee was notified by letter, hand delivered by Cook sales representative on 1/19/2004.
Biliary Stent Introducer Set
The guiding catheter provided with the SIS-10 biliary stent introduction system may be a 5 French instead of the required 6 French guiding catheter.
Consignees were notified on 4/21/2004 via visit by sales representative or fax to international distributor .
AcuSnare Polypectomy Device, Cook Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. The SASM device prefix denotes Soft AcuSnare Mini. The ASM device prefix denotes Acu Snare Mini. Due to the nitinol core wire, the difference between these two products is stiffness of the snare head wire.
The snares inside the box labeled SASM-1 may actually be ASM-1 devices. The individual pouches may be correctly labeled ASM.
Consignees were notified by visit by sales representatives with follow up letter on 4/21/2004.
Howell D.A.S.H. II Access System, Wire Guided Sphincterotome
Wire-Guided Sphinterotomes may be packaged with an incorrect wire guide label.
Consignees were notified by letter sent via Certified Mail on December 17, 2003.
Quantum TTC Biliary Balloon Dilator
The product was labeled 'esophageal', but contained a 'biliary' ballon
The consignees were notified of the recall via letter on September 15, 2003. The bottom portion of the recall communication is to be returned indicating amount of product being returned or indicating no product was to be returned.
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
Mislabeling; Incorrect statement, Minimum Accessory Channel Size: 3.7mm, should state, Minimum Accessory Channel Size 4.2mm
Consignee was notified by letter sent via fax on 12/19/2003.
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.
Complaints were reported of difficulty in stent deployment.
Sales representatives were sent notices via email on April 21, 2002. They were responsible for visiting each of their accounts, inform them of the Market Withdrawal and to return the device for replacement.
APSOF-7-4-RB, ZIMMON PANCREATIC STENT W/RADIOPAQUE BANDS, Stent Diameter: 7 FR., Length (Between Curl and Flap): 4 CM, For Use With Wilson-Cook Stent Introduction System: 7 FR. Minimum Accessory Channel Size: 2.8 MM., Disposable-Single Use Only, Rx Only, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
The label is missing the Rx Only symbol.
The consignee was notified by the sales representative on/about July 29, 2003 via hand delivered letter. The consignee was informed of the recall and was advised to quarantine and return the affected product, via the Territory Manager. The consignee was urged to complete and return the response portion of the letter.
EUSN-19-QC Quick-Core Ultrasound Biopsy Needle, Specimen Notch: 20 MM.; Diameter: 5.2 FR. Tapered to 4.5FR. Length: 138-140 CM. Adjustable Needle: 19 GA. Needle Extension: 0-8 CM. Adjustable Minimum Endoscope Channel: 2.0 MM. Disposable-Single Use Only Sterile Shelf Life: 5 Years, Wilson Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston Salem, NC 27105.
There is a possibility that the affected devices would not capture a biopsy during a procedure.
On April 24, 2002 all field representatives were notified via email and all international accounts via fax. Consignees were advised to quarantine all affected product in their possession and to give the product to their Territory Manager for return. Consignees were urged to complete the bottom portion of the letter and return it via the Territory Manager to Wilson-Cook Medical.
Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6 FR./200 CM. , Shelf Life: 1 Year, Sterile, Disposable, Single Use Only, Wilson-Cook Medical, 4900 Bethania Station Road, Winston-Salem, NC 27105.
The product was labeled with a 5 year expiration date instead of a 1 year expiration date.
Field Representatives were notified via Fax or E-mail in August/September, 2002. After being notified about the recall, field representatives were responsible for notifying facilities about the market withdrawal and for furnishing instructions for returning products for credit.