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U.S. Department of Health and Human Services

Class 2 Device Recall HOLDEX SingleUse Holder PP

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  Class 2 Device Recall HOLDEX SingleUse Holder PP see related information
Date Initiated by Firm June 29, 2011
Date Posted August 08, 2011
Recall Status1 Terminated 3 on November 03, 2011
Recall Number Z-2957-2011
Recall Event ID 59352
510(K)Number K980768  
Product Classification Hypodermic Needle Holder, Single Lumen - Product Code FMI
Product HOLDEX Single-Use Holder PP closed pack.
Greiner Bio-One Austria Gmbh.

A sterile single-use disposable holder with an off-center female luer at the top of the holder and epoxy bonded stainless steel needle on the underside of the holder, recommended for use with commercially available butterfly and luer needles in routine venipuncture procedures.
Code Information Item number: 450263D, Lot number A1008033
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		 At removal of the tube from the holder, the needle may dislodge and blood spill can occur.
FDA Determined
Cause 2		 Other
Action Greiner Bio-One North America, Inc. sent a "Recall HOLDEX Single Use Holder PP" letter dated June 29, 2011 to all affected customers. The letter instructed customers stop distributing the product immediately. A Product Disposition form was provided to be completed and returned to Greiner Bio-One at which time upon receipt, arrangements for product return to Greiner Bio-One will be made for replacement or credit. They were requested to provide a list of their customers to Greiner Bio-One that received the affected item. For additional information call Greiner Bio-One at (888) 266-3883.
Quantity in Commerce 142,400 pieces
Distribution Nationwide Distribution including the states of CA, GA, IL, KS, MA, IL, PA and VA.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = FMI and Original Applicant = GREINER MEDITECH, INC.
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