HOLDEX Single-Use Holder PP closed pack. Greiner Bio-One Austria Gmbh. A sterile single-use disposable holder with an of
FDA device recall Z-2957-2011 · posted 2011-08-08 · Terminated
Recall details
- Recalling firm
- Greiner Bio-One North America, Inc.
- Reason for recall
- At removal of the tube from the holder, the needle may dislodge and blood spill can occur.
- Action taken
- 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
- Status
- Terminated
- Product code
- FMI
- Quantity affected
- 142,400 pieces
- Distribution
- Nationwide Distribution including the states of CA, GA, IL, KS, MA, IL, PA and VA.
- Date initiated
- 2011-06-29
- Date posted
- 2011-08-08
- Date terminated
- 2011-11-03
- Location
- Monroe, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VACUETTE HOLDEX (K980768) | Greiner Meditech, Inc. | 1998-04-09 |