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U.S. Department of Health and Human Services

Class 2 Device Recall S/P Orange

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 Class 2 Device Recall S/P Orangesee related information
Date Initiated by FirmApril 23, 2008
Date PostedNovember 04, 2008
Recall Status1 Terminated 3 on November 26, 2012
Recall NumberZ-0278-2009
Recall Event ID 48739
Product Classification Glucose Tolerance Drink - Product Code MRV
ProductS/P Orange 50g Glucose Tolerance Beverage, 10 oz glass bottles, 12 bottles/case, labeled in part ***Cardinal Health McGaw Park, IL 60085-6787 USA*** For prescription use only. Product is used in support of diagnostics testing for hyperglycemia and hypoglycemia.
Code Information lot 4067, Exp 12-2009
FEI Number 3002879536
Recalling Firm/
Manufacturer		 Nerl Diagnostics LLC
3800 Dillon St
Baltimore MD 21224-5248
For Additional Information ContactTina L. Lombari
401-824-2046
Manufacturer Reason
for Recall		Beverage may contain glass particles.
FDA Determined
Cause 2		Other
ActionThe recalling firm notified distribution centers by letter dated 04/23/08 and advised of a single report of glass found in a bottle. The notifications further advised distributors to quarantine referenced product, notify their customers and return the enclosed reply form. Distributors were requested to return or destroy product for replacement. Please contact NERL Diagnostics, LLC at 1-401-824-2046 for assistance.
Quantity in Commerce25908 bottles
DistributionNationwide.
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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