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U.S. Department of Health and Human Services

Class 3 Device Recall Anaerotest

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 Class 3 Recall
see related information
Date Posted February 17, 2007
Recall Status1 Terminated on June 06, 2008
Recall Number Z-0498-2007
Recall Event ID 37215
Product Classification Transport Systems, Anaerobic - Product Code JTX
Product Anaerotest for microbiology Specification: Performance Test Anerobic: white within 4-6 hours; aerobic: blue with 20 minutes Merck KgaA 64271 Darmstadt, Germany 1.19034.0002 17.08.06 1 unit UPC 4 022536 667928
Code Information Item number 1.19034.0002 Lot # OC553145
Recalling Firm/
EMD Chemicals Inc
480 S Democrat Rd
Gibbstown, New Jersey 08027-1239
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Joseph Scheollkopff
Manufacturer Reason
for Recall
Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment even if oxygen is present.
FDA Determined
Cause 2
DESIGN: Packaging Design/Selection
Action A Recall Letter was issued by EMD Chemicals on 8/17/2006 to discontinue product usage and for product return.
Quantity in Commerce 8 rolls
Distribution Product was only sent to one US customer: Becton Dickinson, Cayey. Pureto Rico.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.