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U.S. Department of Health and Human Services

Class 3 Device Recall OPTI LION EPlus Cassettes

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  Class 3 Device Recall OPTI LION EPlus Cassettes see related information
Date Initiated by Firm April 20, 2009
Date Posted March 11, 2010
Recall Status1 Terminated 3 on April 17, 2012
Recall Number Z-1083-2010
Recall Event ID 54512
510(K)Number K052027  
Product Classification Electrode, ion-specific, chloride - Product Code CGZ
Product OPTI¿¿ LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care.

Intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma.
Code Information Lot numbers: 904801, 904803 and 915800.
Recalling Firm/
Manufacturer		 OPTI Medical Systems, Inc
235 Hembree Park Dr
Roswell GA 30076-5738
For Additional Information Contact Len Owens
770-510-4444 Ext. 573
Manufacturer Reason
for Recall		 Outer box labeling shows an incorrect storage temperature range.
FDA Determined
Cause 2		 Process control
Action OPTI Medical Systems, Inc. issued a "Medical Device Correction" letter dated April 20, 2009. Consignees were instructed on how to corrected the affected product and were asked to return a completed Correction Response Card. For further information, contact OPTI Medical Systems, Inc. at +01 770 510 4444 (outside US) or 1-800-490-6784 (US).
Quantity in Commerce 127 boxes of 25 cassettes each for a total of 3175 cassettes.
Distribution Worldwide Distribution -- United States (CA, KY, MA and OK), Djouti (Africa), Egypt, Guatemala, India, Iraq, Pakistan, United Arab Emirates and Vietnam.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = CGZ and Original Applicant = OSMETECH, INC.
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