Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.
FDA device recall Z-1797-2015 · posted 2015-06-12 · Terminated
Recall details
- Recalling firm
- Amerx Health Care Corp.
- Reason for recall
- Nonapproved labeling claims (Sterile)
- Action taken
- 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 marketcorrection@amerxhc.com.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- MGQ
- Quantity affected
- 6,491 units
- Distribution
- 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
- Date initiated
- 2015-02-25
- Date posted
- 2015-06-12
- Date terminated
- 2016-10-03
- Location
- Clearwater, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMERIGEL OINTMENT SATURATED WOUND DRESSING (K971918) | Amerx Health Care Corp. | 1997-08-12 |
| AMERIGEL OINTMENT (K970133) | Amerx Health Care Corp. | 1997-04-14 |