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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmSeptember 29, 2004
Date PostedOctober 20, 2004
Recall Status1 Terminated 3 on February 08, 2005
Recall NumberZ-0025-05
Recall Event ID 30184
Product Classification Stains, Microbiologic - Product Code JTS
ProductDifco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles, catalog # 212526, staining reagent.
Code Information Lots 4223220, Exp 5/28/05 4226886, Exp 5/28/05 4233156, Exp 5/28/05 4237134, Exp 6/30/05 4226882, Exp 5/28/05 4237144, Exp 6/30/05 
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information ContactCustomer Service Dept
800-675-0908
Manufacturer Reason
for Recall		Reagent for microbiological testing may cause inconsistent staining characteristics and subsequent misidentification of bacteria in patient samples.
FDA Determined
Cause 2		Other
ActionThe recalling firm notified distributors and direct accounts by fax, certified letter, and e-mail on 9/29/04. The notifications advised that staining characteristics may not be appropriate, and that product should be discarded for replacement. Distributors were additionally requested to provide a consignee list for direct notification by BD. Consignees were requested to return response form.
DistributionProduct was sold to distributors and end-users nationwide and to the firm''s international affiliates.
Total Product Life CycleTPLC 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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