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BD Microtainer Tube with Glycolytic Inhibitor, Catalog… recallZ-0957-2007 · Becton Dickinson & Company · initiated May 17, 2007

Terminated All recalls posted in June 2007

Is my device affected?

  1. 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.
  2. If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
  3. 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

Mislabeling : box and bag labels are incorrectly labeled to indicate the product contains Sodium Fluoride/Potassium Oxalate, however the instructions for use and the product itself are correct in the additive indicated and used (Sodium Fluoride/Na2EDTA).

FDA root cause category: Other

What the company is doing

Product Recall letters dated May 1, 2007. were sent to all distributors by first class mail. The letter requested all distributors to examine inventory for specific catalog and lot numbers. It also requested distributors to send a copy of the enclosed customer letter to all customers as a subrecall. BD has contracted a third party (West Inc., Appleton, Wisconsin) to coordinate the mailing to all customers, if the firm chooses to use the third party, or the distributor can send the letters themselves.

Recall details

Recall number
Z-0957-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 17, 2007
Posted by the FDA
Jun 21, 2007
Recalling firm
Becton Dickinson & Company
Quantity
142,800 worldwide
FDA submissions
K002456
Distribution
Worldwide; USA, Canada, Australia, Chile, Columbia, Japan, Malaysia, New Zealand, Singapore, Bangladesh and Indonesia

Product description

BD Microtainer Tube with Glycolytic Inhibitor, Catalog Number 365992, Non Sterile, 200 (4 x 50), 25 degrees C, Becton Dickinson and Company, Franklin Lakes, NJ

Code information (models, lots, serial numbers)

Catalog Number 365992 Lot numbers: 6139630, 6213209, 6296815 and 7059245

Other devices under the same FDA submission

1 device cleared under K002456 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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