HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm…

Date

Nov. 25, 2015

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Ethicon Endo-Surgery Inc

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.

Reason

Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.

Distribution pattern

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.

Quantity

441,490 pieces

Codes and lots

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…

Recall started

Sept. 23, 2015

Device type

Instrument, Ultrasonic Surgical

Root cause (FDA)

Device Design

What the company told customers

On October 5, 2015, the firm sent Urgent Medical Device Recall Removal Letters to their customers.

Recall number

Z-0278-2016

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0278-2016. The agency record governs; check it and the company before acting.