| Class 2 Device Recall Amerigel Daily Dressing Packets | |
Date Initiated by Firm | September 26, 2014 |
Date Posted | December 04, 2014 |
Recall Status1 |
Terminated 3 on October 03, 2016 |
Recall Number | Z-0499-2015 |
Recall Event ID |
69394 |
510(K)Number | K971918 |
Product Classification |
Dressing, wound and burn, hydrogel w/drug and/or biologic - Product Code MGQ
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Product | Amerigel Daily Dressing Packets
Wound management |
Code Information |
Model # A2003, Lot #s: 2WD07 |
Recalling Firm/ Manufacturer |
Amerx Health Care Corp. 1300 S. Highland Avenue Clearwater FL 33756
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For Additional Information Contact | James B. Anderson 727-443-0530 |
Manufacturer Reason for Recall | Formulation deviation |
FDA Determined Cause 2 | Mixed-up of materials/components |
Action | Amerx Health Care Corporation sent an URGENT: DEVICE RECALL letter instructing consignees to examine their inventory and immediately determine if they have any of the Lot numbers on hand and to quarantine the product subject to recall. In addition, if they may have further distributed the product, please notify their customers and/or post the enclosed letter in a visible location for the customer to read. Customers with questions were instructed to call 800-448-9599 or email recall@amerxhc.com.
For questions regarding this recall call 727-443-0530. |
Quantity in Commerce | 1740 |
Distribution | Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia. |
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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510(K) Database | 510(K)s with Product Code = MGQ
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