Ethicon Endo-Surgery Inc


   04 رجب 1428 هـ الموافق 18 يوليو 2007 م
Recalling Firm / Manufacturer Ethicon Endo-Surgery Inc
Product Proximate PPH, Procedure for Prolapse and Hemmorroids Set, REF PPH03. Each set contains: 1 hemorrhoidal circular stapler, 1 suture threader, 1 circular anal dilator, and 1 purse string suture anoscope.
Code Information C4ER8H, C4ET81, C4ET82, C4ET91, C4ET83, C4ET92, C4EU22, C4EU23, C4EU2U, C4EU4M, C4EU4N, C4EU2V, C4EV7K, C4EV7L, C4EV7J, C4EV9D, C4EV9E, C4EW2A, C4EW2W, C4EV9C, C4EW58, C4EW59, C4EW57, C4EW6T, C4EW6U, C4EW8T, C4EW8R, C4EX9V, C4EX9T, C4EY41, C4EY42, C4EY43, C4EX9U, C4EY82, C4EY81, C4EY83, C4EZ1D, C4EF01P, C4F01R, C4F01T, C4F03D, C4F03C, C4F05G, C4F114, C4F116, C4F115, C4F12K, C4F12L, C4F12M, C4F143, C4F142, C4F303, C4F14C, C4F31T, C4F33F, C4F34W, C4F34X, C4F35N, C4F380, C4F406, C4F41E, C4F422, C4F407, C4F42L, C4F433, C4F432, C4F44G, C4F44F, C4F456, C4F455, C4F56C, C4F56D, C4F583, C4F58J, C4F58H, C4F60N, C4F60M, C4F62Y, C4F58T, C4F62Z, C4F630, C4F694, C4F695, C4F72Y, C4F715, C4F850, C4F852, C4F84Z, C4F851, C4F86Z, C4F86W, C4F86X, C4F853, C4F854, C4FD16, C4FD17, C4FD5P, C4FD5R, C4FD9X, C4FD9Y, C4FE58, C4FE59, C4FE7C, C4FE7D, C4F851, C4FF43, C4FF4Y, C4FF4Z, C4FF8N, C4FF8P, C4FG20, C4FG6K, C4FH11, C4FH12, C4FH2P, C4FH2R, C4FH7F, C4FH8X, C4FH8Y, C4FJ00, C4FH7G, C4FJ92, C4FJ8K, C4FK05, C4FL05, C4FK9U, C4FL00, C4FM02, C4FM01, C4FM18, C4FN0L, C4FN0G, C4FN80, C4FN78, C4FN5X, C4FN8P, C4FP0N, C4FP0P, C4FP2W, C4FP2X, C4FP5X, C4FR1V, C4FP9V, C4FR3C, C4FM2R, C4FR79, C4FT0G, C4FR7A, C4FT0F, C4FM2T, C4FT1K, C4FT23, C4FT24, C4FT25, C4FT37, C4FT4D, C4FT38, C4FT5D, C4FU70, C4FV36, C4FV2L, C4FU71, C4FV6Y, C4FV7T, C4FV7V, C4FW0N, C4FW0M, C4FW13, C4FW35, C4FW3P, C4FW3M, C4FW34, C4FW3N, C4FW6P, C4FW6T, C4FX0N, C4FX22, C4FY0A, C4FY0D, C4FY0C, C4FY6F, C4FY6M, C4FY6G, C4FZ1L, C4FZ1K, C4FZ2G, C4FZ3D, C4FZ3E, C4FZ4C, C4FZ1L, C4G001, C4FZ9Z, C4G000, C4G04E, C4G04G, C4G04F, C4G06T, C4G06R, C4G086, C4G108, C4G085, C4G107, C4G12E, C4G148, C4G12F, C4G20Y, C4G20X, C4G23W, D4G34J, D4G34K, D4G34L, D4G37V, D4G37W, D4G460, D4G45Z, D4G483, D4G492, D4G494, D4G484, D4G482, D4G493, D4G49T, D4G63A, D4G63D, D4G63C, D4G851, D4G864, D4G86U, D4G87Y, D4G88Z, D4G890, D4G986, D4G987, D4G985, D4GA22, D4GA23, D4GA21, D4GD5T, D4GD5R, D4GD5U, D4GE16, D4GE17, D4GE6L, D4GE6K, D4GG09, D4GG0A, D4GG0C, D4GG6A, D4GG6C, D4GG8H, D4GG8J, D4GH0Y, D4GH1J, D4GJ0F, D4GH8F, D4GH8D, D4GJ3H, D4GJ3G, D4GJ49, D4GJ5W, D4GJ48, D4GJ7K, D4GJ7P, D4GJ7R, D4GK4D.
Reason of Recall The adhesive used to bond the casing of the device may have migrated to the staple driver. While the device still fires, it may result in audible and tactile feedback at the midpoint of the firing cycle which may be interpreted by some surgeons as a completed firing cycle, which may cause the surgeon to prematurely stop firing the device and result in incomplete staple formation or cut line.
Date Recall Initiated April 02, 2007
Action The recalling firm sent a recall letter dated 04/02/07 to foreign consignees and a second letter dated 04/03/07 to their United States consignees. The letter asks that the customers: 1) Examine their inventories for the presence of the affected product and remove it from inventory if found; 2) Complete the Business Reply Form and fax it to Stericycle their representative and 3) Return all affected product in order to received credit, along with the completed Business Reply Form in the box identified with a pre-printed UPS shipping label supplied by the recalling firm. Firm Initiated recall is ongoing.
Contact johnson & johnson
Jeddah
(02) 6501825
Source of Information U.S. FDA
SFDA Comments SFDA urges all hospitals that have devices subjected to recall, to contact the company.