BOX PST03699 KIT APP MED ALTERNATIV STAP 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.

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.

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": [email protected] or fax to (800) 895-6140. - "Product purchased through distributor": [email protected] or fax it to (203) 492-7719.