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U.S. Department of Health and Human Services

Class 2 Device Recall 15FR Drain Kit Full Fluted with Trocar and 100ml SVac Bulb, Sterile (10/case)

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  Class 2 Device Recall 15FR Drain Kit Full Fluted with Trocar and 100ml SVac Bulb, Sterile (10/case) see related information
Date Initiated by Firm March 20, 2014
Date Posted April 07, 2014
Recall Status1 Terminated 3 on November 25, 2014
Recall Number Z-1425-2014
Recall Event ID 67757
Product Classification Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
Product 15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case)

Intended for closed wound suction drainage
Code Information Product Number 332264
Recalling Firm/
Aspen Surgical Products, Inc.
6945 Southbelt Dr Se
Caledonia MI 49316-7664
For Additional Information Contact
Manufacturer Reason
for Recall
The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
FDA Determined
Cause 2
Packaging process control
Action Aspen Surgical sent an Urgent Medical Device Recall letter dated March 20, 2014, to all affected customers and will be carried out at the distributor and retailer level, which can include doctor's offices, hospitals, and clinics. The distributor was instructed to contact their local FDA District office, conduct a sub-recall and to forward this Recall Notification and Response form to their retailers. A written notification to the consignees was sent by certified mail. Aspen has given the customers the option to either 1.) Return the product 2.) Destroy the product with a Certificate of Destruction to be provided to Aspen. Any returned product to Aspen will be put on MRB and dispositioned by Quality. The returned product will not be reprocessed. In order to determine effectiveness of the recall, any consignee that does not return the response form and/or product, will be contacted within three weeks of receipt of the Recall letter. Non-responders will be contacted a total of three (3) times in order to verify the effectiveness of the recall activity. Customers with questions were instructed to call 888-364-7004, ext 177 or 1-888-364-7004, ext. 156. For questions regarding this recall call 616-698-7100.
Distribution Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.
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.