| Class 2 Device Recall 7mm Drain Kit Flat Full Perforated with 100ml SVac Bulb Evacuator, Sterile (10/case) |  |
Date Initiated by Firm | March 20, 2014 |
Date Posted | April 07, 2014 |
Recall Status1 |
Terminated 3 on November 25, 2014 |
Recall Number | Z-1430-2014 |
Recall Event ID |
67757 |
Product Classification |
Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
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Product | 7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case)
Intended for closed wound suction drainage |
Code Information |
Product Number 340006 |
Recalling Firm/ Manufacturer |
Aspen Surgical Products, Inc. 6945 Southbelt Dr Se Caledonia MI 49316-7664
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For Additional Information Contact | 616-698-7100 |
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 |
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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.
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