Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fa
FDA device recall Z-2640-2014 · posted 2014-09-12 · Terminated
Recall details
- Recalling firm
- Amerx Health Care Corp.
- Reason for recall
- Not approved labeling claims (antimicrobial and autolytic debridement)
- Action taken
- On July 21, 2014, Amerx Health Care Corporation telephoned all affected customers advising them of the recalled products. During the call the customers were instructed to: 1) Discontinue dispensing the lot(s) and promptly return via parcel post to the Clearwater facility. 2) If you dispose of the product on your own, provide proof of disposal. 3) You will be reimbursed by check or credit memo for returned or disposed goods and postage.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- MGQ
- Quantity affected
- 116,633 units
- Distribution
- Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, ME, MD,
- Date initiated
- 2014-07-11
- Date posted
- 2014-09-12
- Date terminated
- 2015-07-22
- 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 |