FDA Device

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.

Hazard

The expiration date listed on the product label is greater than the vendor recommended expiration date.

What You Should Do

Remedy

Consignees were notified by certified mail on 04/01/2005.

Products

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
Brand
Wilson-Cook Medical Inc
UPC
Product Order #ESD-5:  Lot #1519202, Vendor Exp. 05/2002 * Label Exp. 08/2006, Lot #1520620, Vendor Exp. 05/2002 * Label Exp. 08/2006, Lot #1521208, Vendor Exp. 06/2003 * Label Exp. 08/2006, Lot #1521209, Vendor Exp. 06/2003 * Label Exp. 08/2006, Lot #1521210, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1521211, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1537952, Vendor Exp. 06/2003 * Label Exp. 08/2006, Lot #1540901, Vendor Exp. 06/2003 * Label Exp. 08/2006, Lot #1540902, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1541688, Vendor Exp 06/2003 * Label Exp. 09/2006, Lot #1542196, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1545823, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1546030, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1548352, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1550759, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1551793, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1553535, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1577921, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1577922, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1577923, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1581400, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1582964, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1584872, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1584573, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1584928, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1585415, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1593074, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1595660, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1595661, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1595662, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1595663, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1695664, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1695665, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1595666, Vendor Exp. 09/2003 * Label Exp. 03/2007.

Units Affected

167 units