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Terminated

Calcium Sulfate Hemihydrate 0.5 gram kits.

FDA Recall Z-1805-2010 · Posted 2010-06-16

Recalling FirmAce Surgical Supply Co., Inc.
Recall StatusTerminated
Product CodeLYC
Date Initiated2010-05-14
Date Terminated2012-02-02
Product Quantity4133

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.

Firm Action

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

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051381ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATEAce Surgical Supply Co., Inc. · 2005-07-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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