Class 2 Device Recall USPACK Suture kit

• Date Initiated by Firm: May 03, 2017
• Create Date: June 14, 2017
• Recall Status: Terminated on July 18, 2019
• Recall Number: Z-2546-2017
• Recall Event ID: 77144
• Product Classification: Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
• Product: USPACK-SUTURE KIT; Item Number: US1672
• Code Information: A5D0789X
• Recalling Firm/ Manufacturer: Medtronic; 60 Middletown Ave; North Haven CT 06473-3908
• For Additional Information Contact: 800-962-9888 Ext. 2
• Manufacturer Reason for Recall: Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
• FDA Determined Cause: Process control
• Action: All consignees were notified via Federal Express or certified mail on May 3, 2017, and the letter informs customers of the potential for an incomplete seal on the inner package and the actions they should take. Customers are requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice.
• Quantity in Commerce: 478,465 (total for all products)
• Distribution: Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.