Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Recall
Anaerotest 		see related information
Date Posted February 17, 2007
Recall Number Z-0498-2007
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/
Manufacturer		 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
856-423-6300
Reason for
Recall		 Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment even if oxygen is present.
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.
 
-
-