Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with instructions for use.
Recall
- Recall Number
- Z-1935-2012
- Event Number
- 62447
- Firm
- Greiner Bio-One North America, Inc.
- FEI Number
- 3001451379
- Product Code
- FMI
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- April 2, 2012
- Posted
- July 3, 2012
- Terminated
- February 27, 2013
- Address
- 4238 Capital Dr, Monroe, NC, 28110
Description
Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with instructions for use.
: 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.
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 [email protected]. 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.
Nationwide Distribution including IL, MS, OH, PA, TN and VA.
19.5 cases (5,850 pieces) and 244 cases (73,200 pieces)= 263.5 (73258 pieces total)