Amerigel Saturated Gauze Dressing Wound management
FDA device recall Z-0500-2015 · posted 2014-12-04 · Terminated
Recall details
- Recalling firm
- Amerx Health Care Corp.
- Reason for recall
- Formulation deviation
- Action taken
- 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.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- MGQ
- Quantity affected
- 21,108
- 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
- Date initiated
- 2014-09-26
- Date posted
- 2014-12-04
- 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 |