PlainRecordsFDA · Medical device recall
Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear… and 14 more products
- Date posted by the FDA
- Dec. 17, 2003
- Status
- Terminated
- Filed by
- Ethicon Endo-Surgery
- Reason
- A defective articulation band may result in improper staple formation with possible hematosis.
- Distribution pattern
- The product was shipped to hospitals and distributors located nationwide and worldwide.
15 products in this recall
Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter…
- Product
- Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm Standard, Product #ATB35.
- Quantity
- 16,962
- Codes and lots
- Lot Numbers: T4VP02, T4VU1R, T4VV8G, T4VY38, T4W14P, T4W31X, T4W40L, T4W49R, T4W78J, T4W94K, T4W94L, T4WD1Z, T4WE79, T4WG29, T4WH7T, T4WP20, T4WP6M, T4WR1U, T4WV5C, T4WV5D, T4WX38, T4WY96, T4WY9P, T4WZ5H, T4X06W, T4X19X, T4X19Y, T4X21T, T4X54V, T4X84D, T4XC4X, T4XC4Y, T4XD42, T4XD46, T4XE9P, T4XF1L, T4XM0T, T4XM0U, T4XN1K, T4XV2R, T4XV2T, T4XW1U, T4XW1V, T4XZ65, T4Y28Z, T4Y465, T4Y466, T4Y77P, T4Y801.
- Recall started
- Nov. 25, 2003
- Device type
- Staple, Implantable
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
- Recall number
- Z-0212-04
Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter…
- Product
- Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm Vascular/Thin, Product #ATW35.
- Quantity
- 49,395
- Codes and lots
- Lot Numbers: T4VM9R, T4VN0R, T4VNOX, T4VP71, T4VR0U, T4VR3F, T4VR8Z, T4VT68, T4VT75, T4VU1Z, T4VV8U, T4VW33, T4VW34, T4VW7F, T4VW97, T4VX7P, T4VX7R, T4W03T, T4W11A, T4W11X, T4W188, T4W189, T4W31Y, T4W66N, T4W66T, T4W67V, T4W70V, T4W86G, T4W86H, T4W86N, T4WA3R, T4WA6T, T4WA9Z, T4WD68, T4WD6L, T4WD6M, T4WG04, T4WG05, T4WG4K, T4WG6T, T4WG90, T4WH0K, T4WH5J, T4WH5X, T4WH7N, T4WH9G, T4WK6Z, T4WK70, T4WL2U, T4WM6V, T4WN19, T4WN2K, T4WT0F, T4WT0G, T4WU2P, T4WU4L, T4WU5G, T4WU9W, T4WV7E, T4WV8X, T4WX7E, T4WY7P, T4WY7R, T4WZ62, T4X11U, T4X15M, T4X16G, T4X27L, T4X28X, T4X35P, T4X367, T4X46T, T4X46U, T4X631, T4X634, T4X706, T4X707, T4X708, T4X78T, T4X83P, T4X904, T4X905, T4X929, T4XA2Z, T4XA30, T4XC31, T4XE0A, T4XE20, T4XE21, T4XE8Z, T4XE9M, T4XE9N, T4XG9Y, T4XG9Z, T4XH00, T4XH01, T4XK06, T4XK08, T4XK09, T4XM47, T4XM48, T4XM7L, T4XN4Z, T4XN53, T4XN5N, T4XR2N, T4XR2R, T4XT15, T4XU8W, T4XV2K, T4XV2N, T4XW40, T4XW79, T4XZ9L, T4Y01X, T4Y02U, T4Y16K, T4Y16L, T4Y16M, T4Y21N, T4Y21P, T4Y21R, T4Y26W, T4Y26X, T4Y272, T4Y39G, T4Y39L, T4Y634, T4Y635, T4Y636, T4Y75M, T4Y75N, T4Y75P, T4Y75R, T4Y75T, T4YA05, T4YA06, T4YC2K, T4YC2M, T4YC2P.
- Recall started
- Nov. 25, 2003
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
- Recall number
- Z-0213-04
FlexTray Procedure Delivery System Endopath Gynecology Tray…
- Product
- FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FD065.
- Quantity
- 60
- Codes and lots
- Lot Numbers: T4W63C, T4WA2D, T4WD82, T4WT5U, T4Y19Z.
- Recall started
- Nov. 25, 2003
- Device type
- Laparoscope, Gynecologic (And Accessories)
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
- Recall number
- Z-0214-04
FlexTray Procedure Delivery System Endopath Gynecology Tray…
- Product
- FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FD063.
- Quantity
- 210
- Codes and lots
- Lot Numbers: T4W23Y, T4WA33, T4WN15, T4WN5A, T4XY22, T4XZ1E.
- Recall started
- Nov. 25, 2003
- Device type
- Laparoscope, Gynecologic (And Accessories)
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
- Recall number
- Z-0215-04
FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray…
- Product
- FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #FBW24.
- Quantity
- 411
- Codes and lots
- Lot Numbers: T4VZ68, T4W30K, T4W881, T4WL7Z, T4WR5X, T4WT38, T4WY34, T4X38G, T4X52L, T4YC9J.
- Recall started
- Nov. 25, 2003
- Device type
- Instrument, Ultrasonic Surgical
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
- Recall number
- Z-0216-04
FlexTray Procedure Delivery System Endopath Gynecology Tray…
- Product
- FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FD064.
- Quantity
- 72
- Codes and lots
- Lot Numbers: T4W19H, T4WN1J.
- Recall started
- Nov. 25, 2003
- Device type
- Laparoscope, General & Plastic Surgery
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
- Recall number
- Z-0217-04
FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray…
- Product
- FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #KBW16.
- Quantity
- 24
- Codes and lots
- Lot Numbers: T4XD0F, T4XK71
- Recall started
- Nov. 25, 2003
- Device type
- Instrument, Ultrasonic Surgical
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
- Recall number
- Z-0218-04
FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray…
- Product
- FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #KNB21.
- Quantity
- 36
- Codes and lots
- Lot Numbers: T4VT9K, T4Y61F
- Recall started
- Nov. 25, 2003
- Device type
- Laparoscope, General & Plastic Surgery
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
- Recall number
- Z-0219-04
FlexTray Procedure Delivery System Endopath General Laparoscopic Tray…
- Product
- FlexTray Procedure Delivery System Endopath General Laparoscopic Tray, Product #TGL22.
- Quantity
- 102
- Codes and lots
- Lot Numbers: T4VU41, T4VY0X, T4W345, T4W346, T4WY38, T4X059, T4X33K, T4YC9Z, T4YE00.
- Recall started
- Nov. 25, 2003
- Device type
- Instrument, Ultrasonic Surgical
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
- Recall number
- Z-0220-04
General Laparoscopic Tray…
- Product
- General Laparoscopic Tray, Product #TGL33.
- Quantity
- 36
- Codes and lots
- Lot Numbers: T4WF6D, T4WT8Y, T4X52J, T4Y03E.
- Recall started
- Nov. 25, 2003
- Device type
- Instrument, Ultrasonic Surgical
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
- Recall number
- Z-0221-04
General Laparoscopic Tray…
- Product
- General Laparoscopic Tray, Product #TGL53.
- Quantity
- 9
- Codes and lots
- Lot Numbers: T4WP5P
- Recall started
- Nov. 25, 2003
- Device type
- Instrument, Ultrasonic Surgical
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
- Recall number
- Z-0222-04
FlexTray Procedure Delivery System Endopath General Laparoscopic Tray…
- Product
- FlexTray Procedure Delivery System Endopath General Laparoscopic Tray, Product #TGL56.
- Quantity
- 6
- Codes and lots
- Lot Numbers: T4YD0G
- Recall started
- Nov. 25, 2003
- Device type
- Instrument, Ultrasonic Surgical
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
- Recall number
- Z-0223-04
FlexTray Procedure Delivery System Endopath Gynecololgy Tray…
- Product
- FlexTray Procedure Delivery System Endopath Gynecololgy Tray, Product #FN065.
- Quantity
- 45
- Codes and lots
- Lot Numbers: T4VX78, T4WK0G, T4WL8T, T4XH6P, T4Y96L.
- Recall started
- Nov. 25, 2003
- Device type
- Laparoscope, Gynecologic (And Accessories)
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
- Recall number
- Z-0224-04
FlexTray Procedure Delivery System Endopath Gastric Tray…
- Product
- FlexTray Procedure Delivery System Endopath Gastric Tray, Product #KGB11.
- Quantity
- 60
- Codes and lots
- Lot Numbers: T4VN3C, T4W02R, T4W76M, T4WA05, T4WK2N, T4X33J.
- Recall started
- Nov. 25, 2003
- Device type
- Instrument, Ultrasonic Surgical
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
- Recall number
- Z-0225-04
FlexTray Procedure Delivery System Endopath General Laparoscopic Tray…
- Product
- FlexTray Procedure Delivery System Endopath General Laparoscopic Tray, Product #TGL45.
- Quantity
- 102
- Codes and lots
- Lot Numbers: T4WX67, T4X22Y, T4X95D, T4XG4C, T4XK7M, T4XM7U, T4XY24, T4Y32W.
- Recall started
- Nov. 25, 2003
- Device type
- Instrument, Ultrasonic Surgical
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
- Recall number
- Z-0226-04
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0212-04, Z-0213-04, Z-0214-04, Z-0215-04, Z-0216-04, Z-0217-04, Z-0218-04, Z-0219-04 and others. The agency record governs; check it and the company before acting.