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Class 3 Device Recall Harleco Brand |
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Date Initiated by Firm |
December 13, 2002 |
Date Posted |
March 26, 2003 |
Recall Status1 |
Terminated 3 on May 08, 2003 |
Recall Number |
Z-0684-03 |
Recall Event ID |
25298 |
510(K)Number |
K990516
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Product Classification |
Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical - Product Code LCH
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Product |
Ethanol Standard, 0.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case. Item Number 68988/95 |
Code Information |
Item #68988/95; Lot #2330; Exp. Date May 31, 2005 |
Recalling Firm/ Manufacturer |
EMD Chemicals Inc 480 Democrat Road Gibbstown NJ 08027
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For Additional Information Contact |
Anna Bentley 856-423-6300
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Manufacturer Reason for Recall |
The Ethanol Standard is OOS on the low end. The results were 0.44 mg/mL while the specification is 0.48-0.52 mg/mL.
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FDA Determined Cause 2 |
Other |
Action |
All customers were nofitied by phone and letter. The first notification occurred on 12/17/2002 followed with additional notifications on 1/24/2003, 1/28/2003, and 2/4/2003. |
Quantity in Commerce |
139 cases of 10 ampules |
Distribution |
The Ethanol Products were distributed nationwide by the following distributors:
VWR International, 1310 Goshen Pkwy, West Chester, PA 19380;
Government Scientific, 8460 K-Tyco Road, Vienna, VA 22182;
Allegiance Healthcare, 1430 Waukegan Rd., McGaw Park, IL 60085;
Fisher Scientific, 2000 Park Lane, Pittsburgh, PA 15275;
Hawaii Chemical Co., 2363 North King Street, Honolulu, HI 96819;
Krackeler Scientific Inc., 57 Broadway, Albany, NY 12202;
Midland Scientific Inc., 1202 South 11th St., Omaha, NE 68108;
Reagents, Inc. 4746 Sweden Rd., Charlotte, NC 28224.
The Papanicolaou Stain was distributed nationwide by the following distributors:
VWR International, 1310 Goshen Pkwy, West Chester, PA 19380;
Fisher Scientific, 2000 Park Lane, Pittsburgh, PA 15275;
Kramer Scientific, 711 Executive Blvd, Valley Cottage, NY 10989;
Laboratory Supply Company, 3069 Mercury Rd., Jacksonville, FL 32207;
Allegiance Healthcare, 1430 Waukegan Rd., McGaw Park, IL 60085;
Infolab, 3000 Greenhill Dr., Round Rock, TX 78664;
Government Scientific, 8460 K-Tyco Road, Vienna, VA 22182. |
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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510(K) Database |
510(K)s with Product Code = LCH and Original Applicant = EMD CHEMICALS INC.
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