Calcium Sulfate Hemihydrate 0.5 gram kits.
- Company
- Ace Surgical Supply Co., Inc.
- Recall Initiated
- May 14, 2010
- Posted
- June 16, 2010
- Terminated
- February 2, 2012
- Recall Number
- Z-1805-2010
- Quantity
- 4133
- Firm Location
- Brockton, MA
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.
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 505-2002: Australia, Bermuda, Canada, Lebanon, Petaling Jaya, Malaysia, and Portugal.
Lot / Code Info
Calcium Sulfate Hemihydrate 0.5 gram Product Code #5052002 lot numbers 08030107, 08040061, 08050021, 08080027, 08100091, 08120045, 09010054, 09020040, 09020043, 09030046, 09040018, 09050032,09060094, 09070045, 09090002, 09100001, 09100067, 09120012, 10010008, 10010068, 10010069, 10020065, 10030002, 10030059, 10030061, 10040012
Root Cause
Process control
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.