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Terminated

Amerigel Hydrogel Wound Dressing Wound management

FDA Recall Z-0497-2015 · Posted 2014-12-04

Recalling FirmAmerx Health Care Corp.
Recall StatusTerminated
Product CodeMGQ
Date Initiated2014-09-26
Date Terminated2016-10-03
Product Quantity340,896

Reason for Recall

Formulation deviation

Firm 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 [email protected]. For questions regarding this recall call 727-443-0530.

Root Cause

Mixed-up of materials/components

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K971918AMERIGEL OINTMENT SATURATED WOUND DRESSINGAmerx Health Care Corp. · 1997-08-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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