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Class 2 Device Recall SSCOR Powered Suction Device |
 |
| Date Initiated by Firm |
January 06, 2005 |
| Date Posted |
January 27, 2005 |
| Recall Status1 |
Terminated 3 on June 13, 2011 |
| Recall Number |
Z-0412-05 |
| Recall Event ID |
30845 |
| Product Classification |
Pump, Portable, Aspiration (Manual Or Powered) - Product Code BTA
|
| Product |
SSCOR Suction Device Model 2310V |
| Code Information |
Serial Number: D00150 - D00159 |
Recalling Firm/
Manufacturer |
S S C O R Inc
11064 Randall St
Sun Valley CA 91352-2621
|
| For Additional Information Contact |
Jesus (Jesse) Gasaway
818-504-4054
|
Manufacturer Reason
for Recall |
Reports from medical professionals that SSCOR suction device has not performed as intended. Firm's investigation disclosed that the condition in questions is caused by cracked regulators that result in inadequate suction.
|
FDA Determined
Cause 2 |
Other |
| Action |
SSCOR Powered Suction Device not performing as intended. |
| Quantity in Commerce |
16 |
| Distribution |
CA, FL, IA, IL, IN, KY, MO, NC, NJ, NY, OH, France, New Zealand, Singapore, United Kingdom |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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