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Microtainer Brand Tube with EDTA (K2), Catalog Number 365974 recallZ-0447-03 · Becton Dickinson & Company · initiated Oct 16, 2002

Terminated All recalls posted in January 2003

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

Insufficient amount of EDTA found within the tube causing clotting and erroneous platelet counts.

FDA root cause category: Other

What the company is doing

Becton Dickinson contacted their Distributors and customers with return instructions via certified mail on or about Oct. 16, 2002.

Recall details

Recall number
Z-0447-03
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 16, 2002
Posted by the FDA
Jan 16, 2003
Recalling firm
Becton Dickinson & Company
Quantity
141600
Product code
JKA
FDA submissions
K940905
Distribution
The firm distributed this product nationwide to wholesalers and direct customers.

Product description

Microtainer Brand Tube with EDTA (K2), Catalog Number 365974.

Code information (models, lots, serial numbers)

Lot #2098765

Other devices under the same FDA submission

2 devices cleared under K940905 — 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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