Quick Shield with Snappy Safety Holder, Greiner bio-one. The VACUETTE QUICKSHIELD with SNAPPY Tube Holder is intended to
FDA device recall Z-0179-2012 · posted 2011-11-09 · Terminated
Recall details
- Recalling firm
- Greiner Bio-One North America, Inc.
- Reason for recall
- Reports of the Vacuette QuickShield Safety Holders breaking during use due to a crack at the holder hub.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FMI
- Quantity affected
- 443,950 pieces
- Distribution
- Nationwide Distribution-USA (nationwide) including the states of CO, IL, KY, NY, PA and VA.
- Date initiated
- 2011-08-11
- Date posted
- 2011-11-09
- Date terminated
- 2012-03-20
- 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 QUICKSHIELD WITH SNAPPY TUDE HOLDER (K102774) | Greiner Bio-One North America, Inc. | 2010-10-15 |