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ECHELON FLEX recallZ-2326-2021 · Ethicon Endo-Surgery Inc · initiated Jun 3, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ethicon Endo-Surgery Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Mislabeled: Labeled on the package as 60mm contains 45mm devices

FDA root cause category: Packaging change control

What the company is doing

Ethicon notified US consignees by Urgent Medical Device removal letter on 6/3/21 via Fed-Ex second day. Ethicon Johnson & Johnson Affiliates in impacted countries will notify their customers and health authorities per their local regulations and procedures. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2. Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this action has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 4. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and email it to Ethicon at [email protected] within three (3) business days. To request a copy of the BRF that may be completed and signed electronically, please email [email protected]. Please return the BRF even if you do not have product subject to this recall. 5. Follow instructions in the letter and immediately return any inventory of ECHELON FLEX" Powered Plus Stapler, Product Code PSEE60A, Lot U94V47. We request that product subject to this recall be returned no later than September 10, 2021 to Ethicon. Any non-affected product and any product returned after the date specified will not receive replacement. 6. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Ethicon. While processing your returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your records. If you have additional questions regarding this voluntary medical device recall or require any assistance with returning product, please contact the Ethicon Res

Recall details

Recall number
Z-2326-2021
Status
Terminated
Initiated by the company
Jun 3, 2021
Recalling firm
Ethicon Endo-Surgery Inc
Quantity
763 eaches
Product code
GDW
FDA submissions
K202665
Distribution
Worldwide distribution - US Nationwide distribution in the states of MD, WA and the countries of Belgium, China, Denmark, Estonia, France, Germany, Italy, Japan, Korea, Latvia, Lithuania, Netherlands, Poland, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom.

Product description

ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Product Code: PSEE60A

Code information (models, lots, serial numbers)

Lot U94V47 Exp Date: July 31, 2023 GTIN: 10705036014607

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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