| | Class 2 Recall
HOLDEX Single-Use Holder PP |  |
| Date Posted |
August 08, 2011 |
| Recall Number |
Z-2957-2011 |
| 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, North Carolina 28110 |
| Consumer Instructions |
Contact the recalling firm for information |
| For Additional Information Contact |
Manfred Abel
704-261-7800
|
Reason for
Recall |
At removal of the tube from the holder, the needle may dislodge and blood spill can occur.
|
| 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. |
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