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U.S. Department of Health and Human Services

Class 2 Device Recall Reprocessed Ethicon Xcel Trocar Sleeve

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  Class 2 Device Recall Reprocessed Ethicon Xcel Trocar Sleeve see related information
Date Initiated by Firm July 10, 2015
Date Posted August 27, 2015
Recall Status1 Terminated 3 on December 04, 2015
Recall Number Z-2468-2015
Recall Event ID 71805
510(K)Number K100080  
Product Classification Laparoscope, general & plastic surgery, reprocessed - Product Code NLM
Product Stryker
Sustainability Solutions
CB5LT
Ethicon Endo-Surgery, Inc.
Excel Trocar Sleeve
w/Stability Sleeve
5mm x 100mm
Reprocessed by Stryker Sustainability Solutions

Product Usage:
The Reprocessed Ethicon ENDOPATH¿ XCEL Universal Trocar Stability Sleeve is a sterile single patient use device with a radiolucent sleeve. The trocar sleeve contains two seals that accommodate instruments 5mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fitting and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
Code Information Lot number 3574704 UDI Code: (01)00885825014421(17)180310(10)3574704 Model Number: CB5ST (labeled as CB5LT)
Recalling Firm/
Manufacturer		 Stryker Sustainability Solutions
1810 W Drake Dr
Tempe AZ 85283-4327
For Additional Information Contact
888-888-3433
Manufacturer Reason
for Recall		 Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# 3574704) were labeled as 100mm models (CB5LT) while the devices inside of the packaging were 75mm models (CB5ST).
FDA Determined
Cause 2		 Labeling mix-ups
Action On 07/10/15 the firm sent out notification letters to all customers. The letter states for the customer to discontinue use of the affected lot, and to use other trocar lots reporcessed by the firm. The firm requests that the Recall Effectiveness Check Form be completed. The firm is going to be sending a sales representative to the facilities to check inventory for the affected trocars. A Recall Effectiveness Check will also be completed. If the form indicates that affected devices remain in inventory a prepaid shipping label will be issued for the return of the product. Customers will receive credit for all affected devices returned. The form must be completed even if no affected devices are found in inventory. Stryker Sustainability Solutions Complaint Hotline: 1-888-888-3433 x5555
Quantity in Commerce 90 devices
Distribution U.S. Nationwide Distribution to the following states of:: NV, NM, TX, and MI.
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 = NLM and Original Applicant = ASCENT HEALTHCARE SOLUTIONS
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