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 2 Recall
HOLDEX®		see related information
Date Posted September 11, 2008
Recall Number Z-2134-2008
Product Vacuette, Plastic Cannula HOLDEX®, Ref 450216, Single packed, sterile, single use disposable tube holder with off center plastic cannula at the top and a stainless steel needle on the underside of the holder. It is intended for use in routine specimen withdrawal from collection bags or bottles through needless cannula ports.
Code Information Item #450216, Lot #A10074, A100745, A100746, A100747, A110749, and A110750.
Recalling Firm/
Manufacturer		 Greiner Bio-One North America, Inc.
4238 Capital Dr
Monroe, North Carolina 28110-7681
For Additional Information Contact Mr. Manfred Abel
704-261-7823
Reason for
Recall		 At removal of the tube from the holder the needle may dislodge and become stuck in the tube stopper with the blunt end of the needle facing out.
Action Consignees were notified by letter on/about 05/16/2008. They were instructed to stop distributing the affected lots immediately and destroy any of the product they may have. A Product Disposition form was attached to be completed and returned via fax to Greiner bio-one. Consignees instructed to notify their customers and to provide Greiner bio-one with a list of their customers that have received the item. If you have any questions contact Manfred Abel at 704-261-7823.
Quantity in Commerce 1,606,005 units
Distribution Class II Recall - Nationwide Distribution.
 
-
-