Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm)… recallZ-1935-2012 · Greiner Bio-One North America, Inc. · initiated Apr 2, 2012
Class II Terminated All recalls posted in July 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Greiner Bio-One North America, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
: 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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1935-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 2, 2012
- Posted by the FDA
- Jul 3, 2012
- Recalling firm
- Greiner Bio-One North America, Inc.
- Quantity
- 19.5 cases (5,850 pieces) and 244 cases (73,200 pieces)= 263.5 (73258 pieces total)
- Product code
- FMI
- FDA submissions
- K072320
- Distribution
- Nationwide Distribution including IL, MS, OH, PA, TN and VA.
Product 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.
Code information (models, lots, serial numbers)
Item #450239, Lot #G110601I and Item #450235, Lot #G110302J.
Other devices under the same FDA submission
1 device cleared under K072320 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Vacuette 450228Greiner Bio-One GmbH · Needle, hypodermic, single lumen2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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