Greiner Bio-One Recalls Vacuette Quickshield Complete Plus Blood Collection Devices
Greiner Bio-One is recalling specific lots of Vacuette Quickshield Complete Plus devices due to a defect that may cause the safety shield to become loose and unstable.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that compromises the safety shield, creating a risk of harm (needlestick injury) even though no specific injuries are reported in the source text.
Plain-English summary
Greiner Bio-One North America, Inc. is voluntarily recalling specific lots of Vacuette Quickshield Complete Plus, 21G x 1 1/4 (0.8 x 25 mm) blood collection devices. The recall affects Item #450239, Lot #G110601I, and Item #450235, Lot #G110302J. The total quantity involved is 263.5 cases, comprising 73,258 pieces.
The recall is being conducted because the Quickshield Complete Plus may have a defect, specifically a split at the base. This defect can cause the green safety shield attachment of the Quickshield holder to be loose and unstable. The devices are intended for single-use by adequately trained healthcare personnel in routine venipuncture procedures.
The affected products were distributed nationwide, including in Illinois, Mississippi, Ohio, Pennsylvania, Tennessee, and Virginia. Healthcare facilities and users should stop using the affected lots and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- 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
- Manufacturer
- Greiner Bio-One North America, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Item #450239
- Lot #G110601I and Item #450235
- Lot #G110302J.
Distribution
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