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U.S. Department of Health and Human Services

Class 2 Device Recall KITDE0080 BYPASS KIT

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 Class 2 Device Recall KITDE0080 BYPASS KITsee related information
Date Initiated by FirmApril 26, 2018
Date PostedMay 16, 2018
Recall Status1 Terminated 3 on June 17, 2020
Recall NumberZ-1837-2018
Recall Event ID 79974
510(K)NumberK111825 
Product Classification Staple, implantable - Product Code GDW
ProductKIT-DE-0080 BYPASS KIT LOHNE X1( Item KIT-DE-0080) 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 0214049646, 0214370002, 0214470664, 0215208426
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 2		Process control
ActionOn 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 Commerce171,271 units in total
DistributionWorldwide and US Nationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GDW
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