Greiner bio-one, VACUETTE TUBE, 9NC Coagulation Citrate… recallZ-1331-04 · Greiner VACUETTE North America · initiated Jul 27, 2004
Terminated All recalls posted in August 2004
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 VACUETTE North America 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
Coagulation tubes may not have received the proper fill of citrate solution.
FDA root cause category: Other
What the company is doing
Consignees were notified by letter on 7/28/2004.
Recall details
- Recall number
- Z-1331-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 27, 2004
- Posted by the FDA
- Aug 10, 2004
- Recalling firm
- Greiner VACUETTE North America
- Quantity
- 314 cases (376,800 pieces)
- Product code
- GIM
- FDA submissions
- K971221
- Distribution
- Nationwide
Product description
Greiner bio-one, VACUETTE TUBE, 9NC Coagulation Citrate 3.2%, 3.5ml blue cap-black ring, 24 racks of 50, 1200 pcs in total, non ridged, sandwich tube, Ref: 454332, Lot B040404, Expiry 2005-04, Sterile.
Code information (models, lots, serial numbers)
Item no. 454332, Lot number B040404
Other devices under the same FDA submission
3 devices cleared under K971221 — 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 454322Greiner Bio-One GmbH · Tubes, vacuum sample, with anticoagulant3 recalls0 reports
- Vacuette 454334Greiner Bio-One GmbH · Tubes, vacuum sample, with anticoagulant1 recall0 reports
- Vacuette 454332Greiner Bio-One GmbH · Tubes, vacuum sample, with anticoagulant1 recall0 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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