Recall Z-1387-2023 ยท GCJ Laparoscope, General & Plastic Surgery
Covidien, LP
Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
| Date | Apr 12, 2023 (initiated Mar 1, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 rs.gmbfcamitg@medtronic.com. " Product purchased directly from Medtronic please contact rs.covidienfeedbackcustomerservice@medtronic.com for Return Goods Authorization (RGA). Your local Medtronic Representative can assist you as necessary in initiating the return |
| Quantity | 770 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961940 | INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP Innerdyne, Inc., Jul 10, 1996 |