| |
Class 2 Device Recall HARMONIC ACE 7 Laparoscopic Shears |
 |
| Date Initiated by Firm |
September 23, 2015 |
| Date Posted |
November 16, 2015 |
| Recall Status1 |
Terminated 3 on November 01, 2016 |
| Recall Number |
Z-0278-2016 |
| Recall Event ID |
72285 |
| 510(K)Number |
K132612
|
| Product Classification |
Instrument, ultrasonic surgical - Product Code LFL
|
| Product |
HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. |
| Code Information |
Model # HARH23: Batch # L90K2V, Exp Date 2019-02; Batch # L90K2W, Exp Date 2019-02; Batch # L90K2X, Exp Date 2019-02; Batch # L90V6P, Exp Date 2019-03; Batch #, L9109W, Exp Date, 2019-03; Batch #, L91739, Exp Date, 2019-04; Batch #, L91F3X, Exp Date, 2019-05; Batch #, L91H6F, Exp Date, 2019-05; Batch #, L91M6D, Exp Date, 2019-06; Batch #, L91W4Z, Exp Date, 2019-06; Batch #, L91Z2W, Exp Date, 2019-07; Batch #, L92002, Exp Date, 2019-07; Batch #, L9214D, Exp Date, 2019-07; Batch #, L92194, Exp Date, 2019-07; Batch #, L92673, Exp Date, 2019-08; Batch #, L92E3H, Exp Date, 2019-08; Batch #, L92G7W, Exp Date, 2019-09; Batch #, L92L5R, Exp Date, 2019-09; Batch #, L92L8T, Exp Date, 2019-09; Batch #, L92R3H, Exp Date, 2019-09; Batch #, L92U7M, Exp Date, 2019-10; Batch #, L92W9M, Exp Date, 2019-10; Batch #, L92Y2K, Exp Date, 2019-10; Batch #, L92Y5M, Exp Date, 2019-10; Batch #, L92Z3M, Exp Date, 2019-10; Batch #, L9361Y, Exp Date, 2019-11; Batch #, M9013T, Exp Date, 2019-12; Batch #, M90214, Exp Date, 2019-12; Batch #, M9029F, Exp Date, 2019-12; Batch #, M9041P, Exp Date, 2019-12; Batch #, M90550, Exp Date, 2019-12; Batch #, M90681, Exp Date, 2019-12; Batch #, M9094Y, Exp Date, 2019-12; Batch #, M90H4Y, Exp Date, 2020-01; Batch #, M90K10, Exp Date, 2020-01; Batch #, M90L6V, Exp Date, 2020-02; Batch #, M90N41, Exp Date, 2020-02; Batch #, M90U2V, Exp Date, 2020-02; Batch #, M90X1T, Exp Date, 2020-02; Batch #, M90Y5Y, Exp Date, 2020-02; Batch #, M9107H, Exp Date, 2020-03; Batch #, M9134X, Exp Date, 2020-03; Batch #, M9159T, Exp Date, 2020-03; Batch #, M91788, Exp Date, 2020-03; Batch #, M9180C, Exp Date, 2020-03; Batch #, M91D2P, Exp Date, 2020-04; Batch #, M91D7P, Exp Date, 2020-04; Batch #, M91E14, Exp Date, 2020-04; Batch #, M91J5X, Exp Date, 2020-04; Batch #, M91L28, Exp Date, 2020-05; Batch #, M91M8D, Exp Date, 2020-05; Batch #, M91P44, Exp Date, 2020-05; Batch #, M91P5A, Exp Date, 2020-05; Batch #, M91T75, Exp Date, 2020-05; Batch #, M91W2T, Exp Date, 2020-05; Batch #, M91W5C, Exp Date, 2020-05; Batch #, M91X4J, Exp Date, 2020-05; Batch #, M91X9A, Exp Date, 2020-06; Batch #, M91X9U, Exp Date, 2020-06; Batch #, M92303, Exp Date, 2020-06; Batch #, M9232T, Exp Date, 2020-06; Batch #, M9237E, Exp Date, 2020-06; Batch #, M9243M, Exp Date, 2020-06; Batch #, M9244V, Exp Date, 2020-06; Batch #, M92795, Exp Date, 2020-07; Batch #, M9283L, Exp Date, 2020-07; Batch #, M9294A, Exp Date, 2020-07; Batch #, M92961, Exp Date, 2020-07; Batch #, M92C66, Exp Date, 2020-07; Batch #, M92C90, Exp Date, 2020-07; Batch #, M92E9X, Exp Date, 2020-07; Batch #, M92G56, Exp Date, 2020-07; Batch #, M92G79, Exp Date, 2020-07; Batch #, M92J3C, Exp Date, 2020-08; Batch #, M92L92, Exp Date, 2020-08 & Batch #, M92N00, Exp Date, 2020-08. Model # HARH36: Batch #, L90K4P, Exp Date, 2019-02; Batch #, L90W33, Exp Date, 2019-03; Batch #, L90W7K, Exp Date, 2019-03; Batch #, L91023, Exp Date, 2019-03; Batch #, L9103T, Exp Date, 2019-03; Batch #, L91080, Exp Date, 2019-03; Batch #, L9110Z, Exp Date, 2019-03; Batch #, L91144, Exp Date, 2019-03; Batch #, L9124Z, Exp Date, 2019-04; Batch #, L9128A, Exp Date, 2019-04; Batch #, L9131N, Exp Date, 2019-04; Batch #, L9138J, Exp Date, 2019-04; Batch #, L9142T, Exp Date, 2019-04; Batch #, L91467, Exp Date, 2019-04; Batch #, L9150V, Exp Date, 2019-04; Batch #, L91562, Exp Date, 2019-04; Batch #, L91884, Exp Date, 2019-04; Batch #, L9191F, Exp Date, 2019-04; Batch #, L91D1W, Exp Date, 2019-05; Batch #, L91D3V, Exp Date, 2019-05; Batch #, L91E0Y, Exp Date, 2019-05; Batch #, L91E5M, Exp Date, 2019-05; Batch #, L91E8N, Exp Date, 2019-05; Batch #, L91H0G, Exp Date, 2019-05; Batch #, L91H9R, Exp Date, 2019-05; Batch #, L91J2N, Exp Date, 2019-05; Batch #, L91K6G, Exp Date, 2019-05; Batch #, L91L6M, Exp Date, 2019-05; Batch #, L91P2Z, Exp Date, 2019-06; Batch #, L91P5D, Exp Date, 2019-06; Batch #, L91P99, Exp Date, 2019-06; Batch #, L91T2H, Exp Date, 2019-06; Batch #, L91T7E, Exp Date, 2019-06; Batch #, L91T9U, Exp Date, 2019-06; Batch #, L91V2X, Exp Date, 2019-06; Batch #, L91V62, Exp Date, 2019-06; Batch #, L91W1T, Exp Date, 2019-06; Batch #, L91X5P, Exp Date, 2019-07; Batch #, L91Y0X, Exp Date, 2019-07; Batch #, L91Y8W, Exp Date, 2019-07; Batch #, L91Z0N, Exp Date, 2019-07; Batch #, L9204R, Exp Date, 2019-07; Batch #, L92092, Exp Date, 2019-07; Batch #, L9225Y, Exp Date, 2019-07; Batch #, L9232V, Exp Date, 2019-07; Batch #, L9238R, Exp Date, 2019-07; Batch #, L9244H, Exp Date, 2019-07; Batch #, L92524, Exp Date, 2019-07; Batch #, L9255U, Exp Date, 2019-08; Batch #, L9259G, Exp Date, 2019-08; Batch #, L9272N, Exp Date, 2019-08; Batch #, L9284X, Exp Date, 2019-08; Batch #, L9285V, Exp Date, 2019-08; Batch #, L9290A, Exp Date, 2019-08; Batch #, L92921, Exp Date, 2019-08; Batch #, L92952, Exp Date, 2019-08; Batch #, L92987, Exp Date, 2019-08; Batch #, L92A89, Exp Date, 2019-08; Batch #, L92C3L, Exp Date, 2019-08; Batch #, L92C57, Exp Date, 2019-08; Batch #, L92D3K, Exp Date, 2019-08; Batch #, L92D4D, Exp Date, 2019-08; Batch #, L92D9H, Exp Date, 2019-08; Batch #, L92E43, Exp Date, 2019-08; Batch #, L92E8A, Exp Date, 2019-08; Batch #, L92F0U, Exp Date, 2019-08; Batch #, L92F2W, Exp Date, 2019-08; Batch #, L92F5A, Exp Date, 2019-09; Batch #, L92G2F, Exp Date, 2019-09; Batch #, L92G4R, Exp Date, 2019-09; Batch #, L92G9M, Exp Date, 2019-09; Batch #, L92J1A, Exp Date, 2019-09; Batch #, L92J1K, Exp Date, 2019-09; Batch #, L92K1F, Exp Date, 2019-09; Batch #, L92K66, Exp Date, 2019-09; Batch #, L92K9X, Exp Date, 2019-09; Batch #, L92P2A, Exp Date, 2019-09; Batch #, L92P4K, Exp Date, 2019-09; Batch #, L92P5A, Exp Date, 2019-09; Batch #, L92R16, Exp Date, 2019-09; Batch #, L92R2M, Exp Date, 2019-09; Batch #, L92R79, Exp Date, 2019-09; Batch #, L92R95, Exp Date, 2019-09; Batch #, L92T2A, Exp Date, 2019-10; Batch #, L92T64, Exp Date, 2019-10; Batch #, L92T6X, Exp Date, 2019-10; Batch #, L92U09, Exp Date, 2019-10; Batch #, L92U51, Exp Date, 2019-10; Batch #, L92U5K, Exp Date, 2019-10; Batch #, L92V39, Exp Date, 2019-10; Batch #, L92V4E, Exp Date, 2019-10; Batch #, L92V89, Exp Date, 2019-10; Batch #, L92W83, Exp Date, 2019-10; Batch #, L92X1Z, Exp Date, 2019-10; Batch #, L92X5D, Exp Date, 2019-10; Batch #, L92X73, Exp Date, 2019-10; Batch #, L92Y5D, Exp Date, 2019-10; Batch #, L92Y9L, Exp Date, 2019-10; Batch #, L92Z0W, Exp Date, 2019-10; Batch #, L92Z1R, Exp Date, 2019-10; Batch #, L92Z7H, Exp Date, 2019-10; Batch #, L9302N, Exp Date, 2019-10; Batch #, L9307C, Exp Date, 2019-10; Batch #, L93086, Exp Date, 2019-10; Batch #, L9311H, Exp Date, 2019-10; Batch #, L93122, Exp Date, 2019-10; Batch #, L93196, Exp Date, 2019-11; Batch #, L93200, Exp Date, 2019-11; Batch #, L9325A, Exp Date, 2019-11; Batch #, L9327J, Exp Date, 2019-11; Batch #, L93280, Exp Date, 2019-11; Batch #, L9330R, Exp Date, 2019-11; Batch #, L9330W, Exp Date, 2019-11; Batch #, L9333C, Exp Date, 2019-11; Batch #, L9334R, Exp Date, 2019-11; Batch #, L9338D, Exp Date, 2019-11; Batch #, L9339Z, Exp Date, 2019-11; Batch #, L9343C, Exp Date, 2019-11; Batch #, L9347A, Exp Date, 2019-11; Batch #, L9348U, Exp Date, 2019-11; Batch #, L9352A, Exp Date, 2019-11; Batch #, L9353X, Exp Date, 2019-11; Batch #, L9353Y, Exp Date, 2019-11; Batch #, L9356M, Exp Date, 2019-11; Batch #, L9361E, Exp Date, 2019-11; Batch #, L9362R, Exp Date, 2019-11; Batch #, L9362Z, Exp Date, 2019-11; Batch #, L9364G, Exp Date, 2019-11; Batch #, M9002F, Exp Date, 2019-12; Batch #, M9004D, Exp Date, 2019-12; Batch #, M9004N, Exp Date, 2019-12; Batch #, M9016Y, Exp Date, 2019-12; Batch #, M9017T, Exp Date, 2019-12; Batch #, M90235, Exp Date, 2019-12; Batch #, M90275, Exp Date, 2019-12; Batch #, M9027Z, Exp Date, 2019-12; Batch #, M9030P, Exp Date, 2019-12; Batch #, M9038T, Exp Date, 2019-12; Batch #, M90444, Exp Date, 2019-12; Batch #, M9046H, Exp Date, 2019-12; Batch #, M90494, Exp Date, 2019-12; Batch #, M9051C, Exp Date, 2019-12; Batch #, M9057H, Exp Date, 2019-12; Batch #, M90601, Exp Date, 2019-12; Batch #, M9064E, Exp Date, 2019-12; Batch #, M9069Y, Exp Date, 2019-12; Batch #, M9071X, Exp Date, 2019-12; Batch #, M90764, Exp Date, 2019-12; Batch #, M9083G, Exp Date, 2019-12; Batch #, M90880, Exp Date, 2019-12; Batch #, M90902, Exp Date, 2019-12; Batch #, M9091P, Exp Date, 2019-12; Batch #, M9097G, Exp Date, 2019-12; Batch #, M90A5M, Exp Date, 2020-01; Batch #, M90A8A, Exp Date, 2020-01; Batch #, M90C39, Exp Date, 2020-01; Batch #, M90C87, Exp Date, 2020-01; Batch #, M90C88, Exp Date, 2020-01; Batch #, M90C89, Exp Date, 2020-01; Batch #, M90D1E, Exp Date, 2020-01; Batch #, M90D8J, Exp Date, 2020-01; Batch #, M90D9T, Exp Date, 2020-01; Batch #, M90E1U, Exp Date, 2020-01; Batch #, M90F06, Exp Date, 2020-01; Batch #, M90F1W, Exp Date, 2020-01; Batch #, M90F3K, Exp Date, 2020-01; Batch #, M90F5Y, Exp Date, 2020-01; Batch #, M90G00, Exp Date, 2020-01; Batch #, M90G2Y, Exp Date, 2020-01; Batch #, M90G78, Exp Date, 2020-01; Batch #, M90G7Y, Exp Date, 2020-01; Batch #, M90H28, Exp Date, 2020-01; Batch #, M90H7D, Exp Date, 2020-01; Batch #, M90H7E, Exp Date, 2020-01; Batch #, M90H84, Exp Date, 2020-01; Batch #, M90J09, Exp Date, 2020-01; Batch #, M90J6R, Exp Date, 2020-01; Batch #, M90J7R, Exp Date, 2020-01; Batch #, M90K0A, Exp Date, 2020-01; Batch #, M90K5F, Exp Date, 2020-01; Batch #, M90K7A, Exp Date, 2020-01; Batch #, M90K8X, Exp Date, 2020-01; Batch #, M90L1F, Exp Date, 2020-02; Batch #, M90L2K, Exp Date, 2020-02; Batch #, M90L3Z, Exp Date, 2020-02; Batch #, M90L6U, Exp Date, 2020-02; Batch #, M90M34, Exp Date, 2020-02; Batch #, M90M52, Exp Date, 2020-02; Batch #, M90N1M, Exp Date, 2020-02; Batch #, M90N4Z, Exp Date, 2020-02; Batch #, M90N7V, Exp Date, 2020-02 , Batch #, M90P2U, Exp Date, 2020-02; Batch #, M90P5J, Exp Date, 2020-02; Batch #, M90P7K, Exp Date, 2020-02; Batch #, M90R0A, Exp Date, 2020-02; Batch #, M90R2M, Exp Date, 2020-02; Batch #, M90R2N, Exp Date, 2020-02; Batch #, M90R4W, Exp Date, 2020-02; Batch #, M90R7W, Exp Date, 2020-02; Batch #, M90T1J, Exp Date, 2020-02; Batch #, M90T73, Exp Date, 2020-02; Batch #, M90T98, Exp Date, 2020-02; Batch #, M90U35, Exp Date, 2020-02; Batch #, M90U7F, Exp Date, 2020-02; Batch #, M90V0Y, Exp Date, 2020-02; Batch #, M90V32, Exp Date, 2020-02; Batch #, M90V5R, Exp Date, 2020-02; Batch #, M90V91, Exp Date, 2020-02; Batch #, M90W3V, Exp Date, 2020-02; Batch #, M90W6F, Exp Date, 2020-02; Batch #, M90W9J, Exp Date, 2020-02; Batch #, M90X29, Exp Date, 2020-02; Batch #, M90X4P, Exp Date, 2020-02; Batch #, M90X7D, Exp Date, 2020-02; Batch #, M90Y2N, Exp Date, 2020-02; Batch #, M90Y3U, Exp Date, 2020-02; Batch #, M90Y6R, Exp Date, 2020-02; Batch #, M90Y7Z, Exp Date, 2020-03; Batch #, M90Y9P, Exp Date, 2020-03; Batch #, M90Z7K, Exp Date, 2020-03; Batch #, M9100N, Exp Date, 2020-03; Batch #, M9101R, Exp Date, 2020-03; Batch #, M9103R, Exp Date, 2020-03; Batch #, M91110, Exp Date, 2020-03; Batch #, M9111J, Exp Date, 2020-03; Batch #, M9113E, Exp Date, 2020-03; Batch #, M9115C, Exp Date, 2020-03; Batch #, M9117X, Exp Date, 2020-03; Batch #, M91206, Exp Date, 2020-03; Batch #, M9122P, Exp Date, 2020-03; Batch #, M9124V, Exp Date, 2020-03; Batch #, M9127U, Exp Date, 2020-03; Batch #, M9129X, Exp Date, 2020-03; Batch #, M9132N, Exp Date, 2020-03; Batch #, M9134W, Exp Date, 2020-03; Batch #, M91398, Exp Date, 2020-03; Batch #, M9141W, Exp Date, 2020-03; Batch #, M9143P, Exp Date, 2020-03; Batch #, M9145E, Exp Date, 2020-03; Batch #, M9152A, Exp Date, 2020-03; Batch #, M9155F, Exp Date, 2020-03; Batch #, M9155G, Exp Date, 2020-03; Batch #, M9161E, Exp Date, 2020-03; Batch #, M9162M, Exp Date, 2020-03; Batch #, M9168V, Exp Date, 2020-03; Batch #, M91713, Exp Date, 2020-03; Batch #, M9172G, Exp Date, 2020-03; Batch #, M9176J, Exp Date, 2020-03; Batch #, M9180D, Exp Date, 2020-03; Batch #, M9180E, Exp Date, 2020-03; Batch #, M91848, Exp Date, 2020-04; Batch #, M91874, Exp Date, 2020-04; Batch #, M91897, Exp Date, 2020-04; Batch #, M91918, Exp Date, 2020-04; Batch #, M91950, Exp Date, 2020-04; Batch #, M91A06, Exp Date, 2020-04; Batch #, M91A3L, Exp Date, 2020-04; Batch #, M91C5U, Exp Date, 2020-04; Batch #, M91C8D, Exp Date, 2020-04; Batch #, M91D6Y, Exp Date, 2020-04; Batch #, M91D8F, Exp Date, 2020-04; Batch #, M91D8P, Exp Date, 2020-04; Batch #, M91E35, Exp Date, 2020-04; Batch #, M91E71, Exp Date, 2020-04; Batch #, M91E8E, Exp Date, 2020-04; Batch #, M91F2E, Exp Date, 2020-04; Batch #, M91F5D, Exp Date, 2020-04; Batch #, M91F88, Exp Date, 2020-04; Batch #, M91G2U, Exp Date, 2020-04; Batch #, M91G35, Exp Date, 2020-04; Batch #, M91G3Z, Exp Date, 2020-04; Batch #, M91G85, Exp Date, 2020-04; Batch #, M91H3F, Exp Date, 2020-04; Batch #, M91H6F, Exp Date, 2020-04; Batch #, M91H9G, Exp Date, 2020-04; Batch #, M91H9H, Exp Date, 2020-04; Batch #, M91J6A, Exp Date, 2020-04; Batch #, M91J7U, Exp Date, 2020-04; Batch #, M91J9U, Exp Date, 2020-04; Batch #, M91J9Y, Exp Date, 2020-04; Batch #, M91J9Z, Exp Date, 2020-04; Batch #, M91K5T, Exp Date, 2020-05; Batch #, M91L4L, Exp Date, 2020-05; Batch #, M91L4R, Exp Date, 2020-05; Batch #, M91L6V, Exp Date, 2020-05; Batch #, M91M03, Exp Date, 2020-05; Batch #, M91M06, Exp Date, 2020-05; Batch #, M91M1Y, Exp Date, 2020-05; Batch #, M91M29, Exp Date, 2020-05; Batch #, M91M35, Exp Date, 2020-05; Batch #, M91M5Z, Exp Date, 2020-05; Batch #, M91M7M, Exp Date, 2020-05; Batch #, M91N0N, Exp Date, 2020-05; Batch #, M91N15, Exp Date, 2020-05; Batch #, M91N2N, Exp Date, 2020-05; Batch #, M91N2P, Exp Date, 2020-05; Batch #, M91N2T, Exp Date, 2020-05; Batch #, M91N6Z, Exp Date, 2020-05; Batch #, M91N9G, Exp Date, 2020-05; Batch #, M91P2C, Exp Date, 2020-05; Batch #, M91P2D, Exp Date, 2020-05; Batch #, M91P8K, Exp Date, 2020-05; Batch #, M91P91, Exp Date, 2020-05; Batch #, M91R04, Exp Date, 2020-05; Batch #, M91R8A, Exp Date, 2020-05; Batch #, M91R8C, Exp Date, 2020-05; Batch #, M91R94, Exp Date, 2020-05; Batch #, M91T18, Exp Date, 2020-05; Batch #, M91T1N, Exp Date, 2020-05; Batch #, M91T2C, Exp Date, 2020-05; Batch #, M91T2M, Exp Date, 2020-05; Batch #, M91T41, Exp Date, 2020-05; Batch #, M91T7A, Exp Date, 2020-05; Batch #, M91T8F, Exp Date, 2020-05; Batch #, M91U2N, Exp Date, 2020-05; Batch #, M91U46, Exp Date, 2020-05; Batch #, M91U72, Exp Date, 2020-05; Batch #, M91U77, Exp Date, 2020-05; Batch #, M91U80, Exp Date, 2020-05; Batch #, M91U8C, Exp Date, 2020-05; Batch #, M91V2E, Exp Date, 2020-05; Batch #, M91V5J, Exp Date, 2020-05; Batch #, M91V72, Exp Date, 2020-05; Batch #, M91V7W, Exp Date, 2020-05; Batch #, M91V80, Exp Date, 2020-05; Batch #, M91W0E, Exp Date, 2020-05; Batch #, M91W38, Exp Date, 2020-05; Batch #, M91W5F, Exp Date, 2020-05; Batch #, M91W88, Exp Date, 2020-05; Batch #, M91W90, Exp Date, 2020-05; Batch #, M91X06, Exp Date, 2020-05; Batch #, M91X32, Exp Date, 2020-05; Batch #, M91X4F, Exp Date, 2020-05; Batch #, M91X4H, Exp Date, 2020-05; Batch #, M91X4K, Exp Date, 2020-05; Batch #, M91X6K, Exp Date, 2020-05; Batch #, M91X7Y, Exp Date, 2020-06; Batch #, M91Y2G, Exp Date, 2020-06; Batch #, M91Y3C, Exp Date, 2020-06; Batch #, M91Y71, Exp Date, 2020-06; Batch #, M91Y8T, Exp Date, 2020-06; Batch #, M91Z0X, Exp Date, 2020-06; Batch #, M91Z23, Exp Date, 2020-06; Batch #, M91Z39, Exp Date, 2020-06; Batch #, M91Z5E, Exp Date, 2020-06; Batch #, M91Z65, Exp Date, 2020-06; Batch #, M92015, Exp Date, 2020-06; Batch #, M9201W, Exp Date, 2020-06; Batch #, M9204A, Exp Date, 2020-06; Batch #, M9204C, Exp Date, 2020-06; Batch #, M9210M, Exp Date, 2020-06; Batch #, M92120, Exp Date, 2020-06; Batch #, M92141, Exp Date, 2020-06; Batch #, M9214Y, Exp Date, 2020-06; Batch #, M9215L, Exp Date, 2020-06; Batch #, M9217U, Exp Date, 2020-06; Batch #, M9219T, Exp Date, 2020-06; Batch #, M9221P, Exp Date, 2020-06; Batch #, M92233, Exp Date, 2020-06; Batch #, M9226X, Exp Date, 2020-06; Batch #, M9228L, Exp Date, 2020-06; Batch #, M9231D, Exp Date, 2020-06; Batch #, M9232M, Exp Date, 2020-06; Batch #, M92356, Exp Date, 2020-06; Batch #, M9237D, Exp Date, 2020-06; Batch #, M9239T, Exp Date, 2020-06; Batch #, M9240M, Exp Date, 2020-06; Batch #, M9241E, Exp Date, 2020-06; Batch #, M9243X, Exp Date, 2020-06; Batch #, M92443, Exp Date, 2020-06; Batch #, M9246N, Exp Date, 2020-06; Batch #, M9249D, Exp Date, 2020-06; Batch #, M92517, Exp Date, 2020-06; Batch #, M9251J, Exp Date, 2020-06; Batch #, M92554, Exp Date, 2020-06; Batch #, M9255P, Exp Date, 2020-06; Batch #, M9259G, Exp Date, 2020-06; Batch #, M9259T, Exp Date, 2020-06; Batch #, M92613, Exp Date, 2020-06; Batch #, M92634, Exp Date, 2020-06; Batch #, M9264E, Exp Date, 2020-06; Batch #, M9264N, Exp Date, 2020-06; Batch #, M92673, Exp Date, 2020-06; Batch #, M9269M, Exp Date, 2020-07; Batch #, M92718, Exp Date, 2020-07; Batch #, M92738, Exp Date, 2020-07; Batch #, M9275D, Exp Date, 2020-07; Batch #, M9275X, Exp Date, 2020-07; Batch #, M92783, Exp Date, 2020-07; Batch #, M9278N, Exp Date, 2020-07; Batch #, M9280J, Exp Date, 2020-07; Batch #, M92839, Exp Date, 2020-07; Batch #, M9284P, Exp Date, 2020-07; Batch #, M92880, Exp Date, 2020-02; Batch #, M92894, Exp Date, 2020-07; Batch #, M92928, Exp Date, 2020-07; Batch #, M92935, Exp Date, 2020-07; Batch #, M9295Y, Exp Date, 2020-07; Batch #, M9295Z, Exp Date, 2020-07; Batch #, M92A3A, Exp Date, 2020-07; Batch #, M92A59, Exp Date, 2020-07; Batch #, M92A84, Exp Date, 2020-07; Batch #, M92A8U, Exp Date, 2020-07; Batch #, M92C0A, Exp Date, 2020-07; Batch #, M92C2U, Exp Date, 2020-07; Batch #, M92C51, Exp Date, 2020-07; Batch #, M92C76, Exp Date, 2020-07; Batch #, M92C8Z, Exp Date, 2020-07; Batch #, M92C9H, Exp Date, 2020-07; Batch #, M92D1U, Exp Date, 2020-07; Batch #, M92D2G, Exp Date, 2020-07; Batch #, M92D6K, Exp Date, 2020-07; Batch #, M92D6N, Exp Date, 2020-07; Batch #, M92D6P, Exp Date, 2020-07; Batch #, M92D6R, Exp Date, 2020-07; Batch #, M92E1F, Exp Date, 2020-07; Batch #, M92E36, Exp Date, 2020-07; Batch #, M92E4N, Exp Date, 2020-07; Batch #, M92E5X, Exp Date, 2020-07; Batch #, M92E6U, Exp Date, 2020-07; Batch #, M92E7R, Exp Date, 2020-07; Batch #, M92E9V, Exp Date, 2020-07; Batch #, M92F1U, Exp Date, 2020-07; Batch #, M92F1V, Exp Date, 2020-07; Batch #, M92F38, Exp Date, 2020-07; Batch #, M92F3A, Exp Date, 2020-07; Batch #, M92F5J, Exp Date, 2020-07; Batch #, M92F7C, Exp Date, 2020-07; Batch #, M92G0M, Exp Date, 2020-07; Batch #, M92G1P, Exp Date, 2020-07; Batch #, M92G41, Exp Date, 2020-07; Batch #, M92G5F, Exp Date, 2020-07; Batch #, M92G7C, Exp Date, 2020-07; Batch #, M92H07, Exp Date, 2020-07; Batch #, M92H13, Exp Date, 2020-07; Batch #, M92H24, Exp Date, 2020-07; Batch #, M92H3H, Exp Date, 2020-07; Batch #, M92H4M, Exp Date, 2020-07; Batch #, M92H7D, Exp Date, 2020-07; Batch #, M92H9Z, Exp Date, 2020-07; Batch #, M92J2Y, Exp Date, 2020-07; Batch #, M92J9Z, Exp Date, 2020-08; Batch #, M92K27, Exp Date, 2020-08; Batch #, M92K36, Exp Date, 2020-08; Batch #, M92K53, Exp Date, 2020-08; Batch #, M92K71, Exp Date, 2020-08; Batch #, M92K7F, Exp Date, 2020-08; Batch #, M92L14, Exp Date, 2020-08; Batch #, M92L1L, Exp Date, 2020-08; Batch #, M92L1V, Exp Date, 2020-08; Batch #, M92M3V, Exp Date, 2020-08; Batch #, M92M76, Exp Date, 2020-08; Batch #, M92M9G, Exp Date, 2020-08; Batch #, M92N2A, Exp Date, 2020-08; Batch #, M92N4Y, Exp Date, 2020-08 & Batch #, M92N72, Exp Date, 2020-08. Model # HARH45: Batch #, L90K4R, Exp Date, 2019-02; Batch #, L90V8F, Exp Date, 2019-03; Batch #, L90X10, Exp Date, 2019-03; Batch #, L91358, Exp Date, 2019-04; Batch #, L91600, Exp Date, 2019-04; Batch #, L9166U, Exp Date, 2019-04; Batch #, L9168T, Exp Date, 2019-04; Batch #, L91809, Exp Date, 2019-04; Batch #, L91E83, Exp Date, 2019-05; Batch #, L91G7W, Exp Date, 2019-05; Batch #, L91J6R, Exp Date, 2019-05; Batch #, L91M0D, Exp Date, 2019-06; Batch #, L91M6C, Exp Date, 2019-06; Batch #, L91R4J, Exp Date, 2019-06; Batch #, L91U69, Exp Date, 2019-06; Batch #, L91W66, Exp Date, 2019-06; Batch #, L91Y4Y, Exp Date, 2019-07; Batch #, L91Z72, Exp Date, 2019-07; Batch #, L9207J, Exp Date, 2019-07; Batch #, L92360, Exp Date, 2019-07; Batch #, L9236W, Exp Date, 2019-07; Batch #, L9246M, Exp Date, 2019-07; Batch #, L9252P, Exp Date, 2019-07; Batch #, L9257K, Exp Date, 2019-08; Batch #, L92619, Exp Date, 2019-08; Batch #, L92690, Exp Date, 2019-08; Batch #, L9281C, Exp Date, 2019-08; Batch #, L9288P, Exp Date, 2019-08; Batch #, L9294J, Exp Date, 2019-08; Batch #, L92A2U, Exp Date, 2019-08; Batch #, L92A8A, Exp Date, 2019-08; Batch #, L92C8U, Exp Date, 2019-08; Batch #, L92D7A, Exp Date, 2019-08; Batch #, L92H1J, Exp Date, 2019-09; Batch #, L92H3T, Exp Date, 2019-09; Batch #, L92H79, Exp Date, 2019-09; Batch #, L92H7K, Exp Date, 2019-09; Batch #, L92J40, Exp Date, 2019-09; Batch #, L92K54, Exp Date, 2019-09; Batch #, L92K8Z, Exp Date, 2019-09; Batch #, L92L1C, Exp Date, 2019-09; Batch #, L92M3W, Exp Date, 2019-09; Batch #, L92P9N, Exp Date, 2019-09; Batch #, L92T19, Exp Date, 2019-10; Batch #, L92U1H, Exp Date, 2019-10; Batch #, L92V3L, Exp Date, 2019-10; Batch #, L92V8R, Exp Date, 2019-10; Batch #, L92W46, Exp Date, 2019-10; Batch #, L92X6G, Exp Date, 2019-10; Batch #, L92Y3C, Exp Date, 2019-10; Batch #, L92Y8Z, Exp Date, 2019-10; Batch #, L92Z8P, Exp Date, 2019-10; Batch #, L9303M, Exp Date, 2019-10; Batch #, L93240, Exp Date, 2019-11; Batch #, L93248, Exp Date, 2019-11; Batch #, L93426, Exp Date, 2019-11; Batch #, L9359C, Exp Date, 2019-11; Batch #, M9007E, Exp Date, 2019-12; Batch #, M9007F, Exp Date, 2019-12; Batch #, M90138, Exp Date, 2019-12; Batch #, M9024R, Exp Date, 2019-12; Batch #, M9025P, Exp Date, 2019-12; Batch #, M9030N, Exp Date, 2019-12; Batch #, M9047L, Exp Date, 2019-12; Batch #, M90545, Exp Date, 2019-12; Batch #, M9062G, Exp Date, 2019-12; Batch #, M9080T, Exp Date, 2019-12; Batch #, M90858, Exp Date, 2019-12; Batch #, M9097F, Exp Date, 2019-12; Batch #, M90C11, Exp Date, 2020-01; Batch #, M90C5Y, Exp Date, 2020-01; Batch #, M90D61, Exp Date, 2020-01; Batch #, M90E1V, Exp Date, 2020-01; Batch #, M90F7R, Exp Date, 2020-01; Batch #, M90G3W, Exp Date, 2020-01; Batch #, M90H03, Exp Date, 2020-01; Batch #, M90J4R, Exp Date, 2020-01; Batch #, M90M71, Exp Date, 2020-02; Batch #, M90M9E, Exp Date, 2020-02; Batch #, M90P0E, Exp Date, 2020-02; Batch #, M90T4D, Exp Date, 2020-02; Batch #, M90U8F, Exp Date, 2020-02; Batch #, M90W1V, Exp Date, 2020-02; Batch #, M90X96, Exp Date, 2020-02; Batch #, M90Z1G, Exp Date, 2020-03; Batch #, M90Z52, Exp Date, 2020-03; Batch #, M91053, Exp Date, 2020-03; Batch #, M9125X, Exp Date, 2020-03; Batch #, M9141X, Exp Date, 2020-03; Batch #, M9145F, Exp Date, 2020-03; Batch #, M9164C, Exp Date, 2020-03; Batch #, M9166Y, Exp Date, 2020-03; Batch #, M91984, Exp Date, 2020-04; Batch #, M91D17, Exp Date, 2020-04; Batch #, M91F19, Exp Date, 2020-04; Batch #, M91G1N, Exp Date, 2020-04; Batch #, M91H11, Exp Date, 2020-04; Batch #, M91J0M, Exp Date, 2020-04; Batch #, M91J2G, Exp Date, 2020-04; Batch #, M91L0A, Exp Date, 2020-05; Batch #, M91M1C, Exp Date, 2020-05; Batch #, M91P13, Exp Date, 2020-05; Batch #, M91R3J, Exp Date, 2020-05; Batch #, M91R4M, Exp Date, 2020-05; Batch #, M91R53, Exp Date, 2020-05; Batch #, M91U3L, Exp Date, 2020-05; Batch #, M91V21, Exp Date, 2020-05; Batch #, M91X28, Exp Date, 2020-05; Batch #, M91X4G, Exp Date, 2020-05; Batch #, M91X6W, Exp Date, 2020-06; Batch #, M91Y1Y, Exp Date, 2020-06; Batch #, M91Y3D, Exp Date, 2020-06; Batch #, M91Y7J, Exp Date, 2020-06; Batch #, M9202G, Exp Date, 2020-06; Batch #, M92126, Exp Date, 2020-06; Batch #, M92189, Exp Date, 2020-06; Batch #, M9222C, Exp Date, 2020-06; Batch #, M9224U, Exp Date, 2020-06; Batch #, M9246P, Exp Date, 2020-06; Batch #, M9255N, Exp Date, 2020-06; Batch #, M9273G, Exp Date, 2020-07; Batch #, M92884, Exp Date, 2020-07; Batch #, M9291P, Exp Date, 2020-07; Batch #, M92A24, Exp Date, 2020-07; Batch #, M92A67, Exp Date, 2020-07; Batch #, M92D6L, Exp Date, 2020-07; Batch #, M92E0X, Exp Date, 2020-07; Batch #, M92F1X, Exp Date, 2020-07; Batch #, M92F5K, Exp Date, 2020-07; Batch #, M92F8N, Exp Date, 2020-07; Batch #, M92J31, Exp Date, 2020-08; Batch #, M92J9N, Exp Date, 2020-08; Batch #, M92K6E, Exp Date, 2020-08; Batch #, M92L5C, Exp Date, 2020-08; Batch #, M92L5T, Exp Date, 2020-08; Batch #, M92L7G, Exp Date, 2020-08 & Batch #, M92N47, Exp Date, 2020-08. |
Recalling Firm/
Manufacturer |
Ethicon Endo-Surgery Inc
4545 Creek Rd
Blue Ash OH 45242-2803
|
| For Additional Information Contact |
Mr. Thomas A. Morris
513-337-3419
|
Manufacturer Reason
for Recall |
Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.
|
FDA Determined
Cause 2 |
Device Design |
| Action |
On October 5, 2015, the firm sent Urgent Medical Device Recall Removal Letters to their customers. |
| Quantity in Commerce |
441,490 pieces |
| Distribution |
Distributed US (nationwide) including the District of Columbia & Puerto Rico and in the countries of ARUBA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, ECUADOR, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, MEXICO, PANAMA, PERU, PHILIPPINES, SINGAPORE, SINGAPORE, THAILAND, TAIWAN & VIETNAM. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = LFL and Original Applicant = ETHICON ENDO-SURGERY, LLC
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