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U.S. Department of Health and Human Services

Class 2 Device Recall Amerigel Hydrogel Wound Dressing

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 Class 2 Device Recall Amerigel Hydrogel Wound Dressingsee related information
Date Initiated by FirmMay 20, 2016
Create DateJuly 20, 2016
Recall Status1 Terminated 3 on December 14, 2016
Recall NumberZ-2249-2016
Recall Event ID 74249
510(K)NumberK970133 
Product Classification Lubricant, patient - Product Code KMJ
ProductAmerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.
Code Information Lot # 668
Recalling Firm/
Manufacturer
Amerx Health Care Corp.
1300 S Highland Ave
Clearwater FL 33756-6519
For Additional Information ContactJames Anderson
727-443-0530
Manufacturer Reason
for Recall
Product did not meet specifications for Zinc Acetate (OOS).
FDA Determined
Cause 2
Other
ActionInitial recall notification was sent to distributors, informing them of the voluntary recall and providing instructions on expanding the recall to the wholesale level. Distributors were instructed to identify recalled product in their inventory, quarantine any recalled product, and to complete and fax back a Recall Response Form. Contact information was provided for those with questions: 1-800-448-9599 and recall@amerxhc.com.
Quantity in Commerce6,993 Units
DistributionAR, AZ, CA, CO, CT, FL, GA, IL, IN, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, & Alaska. Bahrain & Colombia.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KMJ
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