FDA Recall Open, Classified

Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), CHROMIC GUT 3-0 75CM V20 X36 (GG-122), CHROMIC GUT 2-0 75CM V20 X36 (GG-123), CHROMIC GUT 2-0 75CM V26 (GG-127), CHROMIC GUT 4-0 45CM P12 X36 (SG-5637), CHROMIC GUT 5-0 45CM P-13 X12 (SG-5687G), CHROMIC GUT 5-0 75CM CV23 (UG-202), CHROMIC GUT 4-0 75CM CV23 X36 (UG-203)

Recall: Z-1388-2023 · Initiated March 1, 2023

Recall

Recall Number: Z-1388-2023
Event Number: 91873
FEI Number: 1219930
Product Code: GAL
Status: Open, Classified
Root Cause: Process control
Initiated: March 1, 2023
Posted: April 12, 2023
Address: LP 60 Middletown Ave, Covidien, North Haven, CT, 06473-3908

Description

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.

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 [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.

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.

Quantity

36204 units