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

Class 2 Device Recall

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


New Search Back to Search Results
 Class 2 Device Recallsee related information
Date Initiated by FirmJanuary 28, 2005
Date PostedMarch 01, 2005
Recall Status1 Terminated 3 on April 13, 2005
Recall NumberZ-0567-05
Recall Event ID 31166
Product Classification Tubes, Vials, Systems, Serum Separators, Blood Collection - Product Code JKA
ProductSterile Empty Vials for Allergenic Extracts, 100ml size
Code Information Item #SE08160, Lot 9406
FEI Number 1011574
Recalling Firm/
Manufacturer		 Greer Laboratories Inc
639 Nuway Circle Ne
P. O. Box 800
Lenoir NC 28645-0800
For Additional Information ContactMark J. Hites RAC
828-754-5327
Manufacturer Reason
for Recall		Product may not be sterile.
FDA Determined
Cause 2		Other
ActionConsignees were first contacted by telephone, followed up with a letter on 01/28/2005.
Quantity in Commerce2157 vials
DistributionAZ, CA, FL, IL,KY, MA,MD, MI, NC, NJ, NM, OH, PA TN, TX, WI, WV, and Ontario Canada.
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.
-
-