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U.S. Department of Health and Human Services

Class 3 Device Recall Harleco Brand

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  Class 3 Device Recall Harleco Brand see related information
Date Initiated by Firm December 13, 2002
Date Posted March 26, 2003
Recall Status1 Terminated 3 on May 08, 2003
Recall Number Z-0685-03
Recall Event ID 25298
Product Classification Stain, Papanicolau - Product Code HZJ
Product Papanicolaou Stain EA-50. Product size configurations: 1L, 4L, and 10L. Item Nos. 7062X/75, 7062X/85, and 7062X/86.
Code Information Item Nos. 7062X/75, 7062X/85, and 7062X/86. Lot #2255 Exp. Date September 30, 2004
Recalling Firm/
Manufacturer		 EMD Chemicals Inc
480 Democrat Road
Gibbstown NJ 08027
For Additional Information Contact Anna Bentley
856-423-6300
Manufacturer Reason
for Recall		 Difficulty in reading slides due to the stain is much greener than normal.
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 232 bottles
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
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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