Reported Nov 25, 2015 · Terminated
HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated…
Ethicon Endo-Surgery Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ethicon Endo-Surgery Inc · 4545 Creek Rd · Blue Ash, OH · 45242-2803
Is this the product you have?
- 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.
- Lot codes and dates
663 of 663 products
Products covered by this recall Model / number Product as published HARH23Batch # 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 - Amount recalled
- 441,490 pieces
Where it was sold
Why it was recalled
Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.
This product could cause temporary or reversible health problems — stop using it.
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