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U.S. Department of Health and Human Services

Class 2 Device Recall Pluerevac Sahara Chest Drainage System

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  Class 2 Device Recall Pluerevac Sahara Chest Drainage System see related information
Date Initiated by Firm March 13, 2015
Date Posted April 08, 2015
Recall Status1 Terminated 3 on August 14, 2017
Recall Number Z-1404-2015
Recall Event ID 70723
510(K)Number K962856  
Product Classification Bottle, collection, vacuum - Product Code KDQ
Product Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.
Code Information Catalogue no. S-1100-08LF, Lot no. 74F1400878
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr
Research Triangle Park NC 27709-0186
For Additional Information Contact Tara Torres-Heckman
610-378-0131
Manufacturer Reason
for Recall		 Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system.
FDA Determined
Cause 2		 Other
Action Teleflex Medical sent an Urgent Medical Device Recall Notification dated March 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any of the affected listed catalog numbers and to return the product. Complete the enclosed acknowledgement form to Teleflex Medical. The form is to be returned even if they have not products. For further questions contact your local sales representative or Customer Service at 1-866 246-6990.
Quantity in Commerce 2,148 units
Distribution US Distribution to the states of : AK, AL, AR, CA, CO, FL, GA, IL, IN, KY, KS, MA, MD, MI, MN, NY, OH, PA, RI, SC, TX, VA WI and WV.
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 = KDQ and Original Applicant = DEKNATEL, INC.
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