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.
FDA Recall Z-2957-2011 · Posted 2011-08-08
Recalling FirmGreiner Bio-One North America, Inc.
Recall StatusTerminated
Product CodeFMI
Date Initiated2011-06-29
Date Terminated2011-11-03
Product Quantity142,400 pieces
Reason for Recall
At removal of the tube from the holder, the needle may dislodge and blood spill can occur.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide Distribution including the states of CA, GA, IL, KS, MA, IL, PA and VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.