Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended t
FDA device recall Z-1935-2012 · posted 2012-07-03 · Terminated
Recall details
- Recalling firm
- Greiner Bio-One North America, Inc.
- Reason for recall
- : The Quickshield Complete Plus may have a defect (split at the base), which can cause the green safety shield attachment of the Quickshield holder to be loose and unstable.
- Action taken
- greiner bio-one sent a notification letter dated April 2, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the attached Product Disposition Site Confirmation form and fax to 800-726-0052 or email to patech@gbo.com. This form will confirm the affected product has been discarded/destroyed. The firm will replace the product after the completed form is returned to them. Customers with questions should call 800-515-8112. For questions regarding this recall call 704-261-7823.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FMI
- Quantity affected
- 19.5 cases (5,850 pieces) and 244 cases (73,200 pieces)= 263.5 (73258 pieces total)
- Distribution
- Nationwide Distribution including IL, MS, OH, PA, TN and VA.
- Date initiated
- 2012-04-02
- Date posted
- 2012-07-03
- Date terminated
- 2013-02-27
- 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 |
|---|---|---|
| GREINER VACUETTE QUICKSHIELD COMPLETE (K072320) | Greiner Bio-One North America, Inc. | 2007-09-14 |