Calcium Sulfate Hemihydrate 1.0 gram kits.
FDA device recall Z-1806-2010 · posted 2010-06-16 · Terminated
Recall details
- Recalling firm
- Ace Surgical Supply Co., Inc.
- Reason for recall
- Fast set 4% potassium sulfate solution may not be sterile. For customers who have used the Calcium Sulfate Hemihydrate kit without the Fast Set solution, then these potential risks identified do not apply. Risks of adverse health consequences with the Fast Set 4% potassium sulfate solution include tissue inflammation and infection.
- Action taken
- Ace Surgical has become aware through internal review of possibility sterility issues with one of the components included in the Calcium Hemihydrate 0.5 and 1.0 gram kits. Customers with questions should contact ACE Surgical using the recall hot line at (800) 441-3100 Ext. 204.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LYC
- Quantity affected
- 7930
- Distribution
- Class 2 recall - Worldwide distribution . Item Number 505-2001: South Africa, Australia, Vietnam, Ontario, Canada, Italy, Lebanon, Petaling Jaya, Malaysia, Portugal, and West Indies. Item Number 505-2
- Date initiated
- 2010-05-14
- Date posted
- 2010-06-16
- Date terminated
- 2012-02-02
- Location
- Brockton, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE (K051381) | Ace Surgical Supply Co., Inc. | 2005-07-15 |