Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in endoscopic surgery for swabbing small amounts of fluid or for blunt dissection of soft tissue(s) and structures, or as an aid in controlling minor intraoperative bleeding
This recall has been terminated (originally issued May 9, 2017).
- Company
- Covidien Llc
- Recall Initiated
- May 9, 2017
- Terminated
- February 13, 2019
- Recall Number
- Z-2622-2017
- Quantity
- 194,851
- Firm Location
- North Haven, CT
- Official Source
- View on FDA website ↗
Reason for Recall
Cotton tip of the device may disengage due to insufficient adhesive
Distribution
Nationwide Distribution
Lot / Code Info
Lot Numbers: M5K04X to M7A01X Exp Date: 2020-October through 2022-January
Root Cause
Process control
Action Taken
Medtronic consignees were notified via Federal Express or certified mail on May 9, 2017, and the letter informs customers of the potential for the tip of the device to disengage from the device and the actions they should take. Accounts requested to discontinue use, quarantine and return product. Customers are requested to complete and acknowledge receipt of the Urgent Field Corrective Action Notice. Questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2. For questions regarding this recall call 203-492-5000.