Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.
FDA Recall Z-1797-2015 · Posted 2015-06-12
Advertisement
Recalling FirmAmerx Health Care Corp.
Recall StatusTerminated
Product CodeMGQ
Date Initiated2015-02-25
Date Terminated2016-10-03
Product Quantity6,491 units
Reason for Recall
Nonapproved labeling claims (Sterile)
Firm Action
On March 9, 2015 the firm contacted its customers via telephone. Within that conversation the firm asked its customers to examine their inventory to determine if they have any of the affected lot numbers on hand and notify the firm for an immediate product substitution, credit or refund. Customers were asked to discontinue dispensing any product on hand, and notify any customers that the product may have been further distributed to. The firm also asked that the response form be completed and returned. If no contact was made via telephone, the firm sent a certified letter asking the firm(s) to do the same actions as the phone request. If you have any questions please call 1-800-448-9599 or e-mail [email protected].
Root Cause
Labeling False and Misleading
Distribution Pattern
Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY and Hawaii; and, the countries of Canada and Bahrain.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement