Date Initiated by Firm |
August 11, 2011 |
Date Posted |
November 09, 2011 |
Recall Status1 |
Terminated 3 on March 20, 2012 |
Recall Number |
Z-0179-2012 |
Recall Event ID |
59918 |
510(K)Number |
K102774
|
Product Classification |
Needle, hypodermic, single lumen - Product Code FMI
|
Product |
Quick Shield with Snappy Safety Holder, Greiner bio-one.
The VACUETTE QUICKSHIELD with SNAPPY Tube Holder is intended to be used only with the VACUETTE Blood Collection Needles and VACUETTE Blood Collection Tubes as a system in routine venipuncture procedures. These devices are to be used by properly trained healthcare professionals only in accordance with these instructions.
|
Code Information |
Item #450254, Lot numbers: B041104, B051105 and B071106. |
Recalling Firm/ Manufacturer |
Greiner Bio-One North America, Inc. 4238 Capital Dr Monroe NC 28110
|
For Additional Information Contact |
Manfred Abel 704-261-7800
|
Manufacturer Reason for Recall |
Reports of the Vacuette QuickShield Safety Holders breaking during use due to a crack at the holder hub.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Greiner Bio-One sent a "QUICKSHIELD WITH SAFETY HOLDER" notification letter dated August 11, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to stop distributing and using the affected products. A Product Disposition Form was attached for customers to complete and return for replacements. Contact the firm at 888-266-3883 for questions concerning this recall. |
Quantity in Commerce |
443,950 pieces |
Distribution |
Nationwide Distribution-USA (nationwide) including the states of CO, IL, KY, NY, PA and VA. |
Total Product Life Cycle |
TPLC Device Report
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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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510(K) Database |
510(K)s with Product Code = FMI and Original Applicant = GREINER BIO-ONE NORTH AMERICA, INC.
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