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U.S. Department of Health and Human Services

Class 2 Device Recall Iris Sample Processing SafeCrit 75mm Tubes

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 Class 2 Device Recall Iris Sample Processing SafeCrit 75mm Tubessee related information
Date Initiated by FirmAugust 01, 2008
Date PostedNovember 07, 2008
Recall Status1 Terminated 3 on December 18, 2008
Recall NumberZ-0208-2009
Recall Event ID 49092
Product Classification Capillary Blood Collection Tube - Product Code GIO
ProductIris Sample Processing SafeCrit 75mm Tubes. Iris Sample Processing, 60 Glacier Drive, Westwood, MA 02090. Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.
Code Information Catalog number 59-002828-001 A - Lot numbers 8129 exp 6/10 and Lot number 8169 exp 7/10 and Catalog number 59-000857-002 G - Lot number 8200 exp 9/10.
Recalling Firm/
Manufacturer		 Drummond Scientific Co
500 Parkway
Broomall PA 19008
For Additional Information ContactBert Moses
610-353-0200
Manufacturer Reason
for Recall		presence of OSCS contaminant
FDA Determined
Cause 2		Material/Component Contamination
ActionThe recalling firm issued recall letters dated 8/1/08 via certified mail to the label owners informing them of the problem and the need to notified their customers.
Quantity in Commerce2000 vials
DistributionNationwide Distribution --- including states of FL and MA.
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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