Class 2 Device Recall Endo GIA" Auto Suture" Universal Articulating Loading Unit

• Date Initiated by Firm: April 26, 2018
• Date Posted: May 16, 2018
• Recall Status: Terminated on June 17, 2020
• Recall Number: Z-1820-2018
• Recall Event ID: 79974
• 510(K)Number: K111825
• Product Classification: Staple, implantable - Product Code GDW
• Product: Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm - 3.5mm ( Item Code 030458); ; Product Usage:; The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.
• Code Information: Lots: N7L0911KX, N7M0067KX, N7F0631KX, N7L0465KX, N7L0117KX, N7L0768KX, N7M0314KX,N7M0314KX,N7L1075KX, N7M0646KX, N7M0740KX, N7M0972KX, N8A0172KX, N8A0539KX, N8A0679KX, N8A0910KX, N8A0961KX, N8B0054KX, N8B0099KX, N8C0008KX, N8C0205KX, N8C0532KX, N8C0571KX, N8C0758KX, N8C0795KX, N8C1284KRX GTIN # 1 (Inner Carton) - 10884523002898 GTIN # 2 (Outer Carton)- 20884523002895
• Recalling Firm/ Manufacturer: COVIDIEN MEDTRONIC; 60 NIDDLETOWN AVE 2ND F; NORTH HAVEN CT 06473
• Manufacturer Reason for Recall: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
• FDA Determined Cause: Process control
• Action: On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423. The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. All in-control inventory and devices returned from customers will be reworked. **FOR INTERNATIONAL CUSTOMERS** Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter. Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO: - "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140. - "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.
• Quantity in Commerce: 171,271 units in total
• Distribution: Worldwide and US Nationwide
• 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.

• 510(K) Database: 510(K)s with Product Code = GDW and Original Applicant = COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H