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Step recallZ-1387-2023 · Covidien, LP · initiated Mar 1, 2023

Open, Classified

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 Covidien, LP 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

Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.

FDA root cause category: Process control

What the company is doing

An "URGENT PRODUCT RECALL" letter dated 3/1/23 was sent to customers. Actions to be Taken: " Immediately identify and quarantine all unused affected product (Refer to Attachment A for identifying affected product). " Please complete and return the enclosed Customer Confirmation Form, even if you have no product to return and email to [email protected]. " Product purchased directly from Medtronic please contact [email protected] for Return Goods Authorization (RGA). Your local Medtronic Representative can assist you as necessary in initiating the return of this product. " Credit for the returned affected product will be issued based on the RGA number. " Return all unused affected product(s) in your inventory to: Medtronic, Attn: Field Returns Dept. 195 McDermott Road, North Haven, CT 06473 USA " If purchased from a distributor, contact your distributor directly to arrange for the return of the product back to your distributor. " Forward this notification to any entities within your organization or to any other organization where the potentially affected product has been transferred or further distributed. Local contact details: Adverse reactions or quality problems experienced with this product should be reported to FDA and Medtronic: " Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail), or Call FDA (800) FDA-1088 " Contact Medtronic Customer Service Support at [email protected] or call 800-962-9888, option 2. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic Representative Customer Service at 800-962-9888, option 2.

Recall details

Recall number
Z-1387-2023
Status
Open, Classified
Initiated by the company
Mar 1, 2023
Posted by the FDA
Apr 12, 2023
Recalling firm
Covidien, LP
Quantity
770 units
Product code
GCJ
FDA submissions
K961940
Distribution
Worldwide Distribution: US (nationwide) to States of: AR, CA, FL, GA, LA, MA, NC, NY, OH, WA; and countries of: Canada, Colombia, El Salvador, Indonesia, Nepal, Puerto Rico, Taiwan, and Thailand.

Product description

Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010

Code information (models, lots, serial numbers)

GTIN: 10884521090767; Lot: P2G0069

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

6 devices cleared under K961940 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 91873).

Sources and updates

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