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BD Vacutainer Urine Complete Kit with UA Preservative Tube… recallZ-1025-2010 · Becton Dickinson & Company · initiated Oct 12, 2009

Terminated All recalls posted in March 2010

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

A small amount of discoloration was noted on Towelettes included in BD Vacutainer Urine collection kits. The entire kit components retain sterile interiors and no viable growth was detected on the towelettes.

FDA root cause category: Other

What the company is doing

Recall notification letters were sent on 10/12/09 with return receipt requested. Customers were advised to contact your SO Sales Consultant for additional information, via e-mail at [email protected] or via telephone at 1-800-6310174.

Recall details

Recall number
Z-1025-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 12, 2009
Posted by the FDA
Mar 8, 2010
Recalling firm
Becton Dickinson & Company
Quantity
226900
Product code
JSM
FDA submissions
K024240
Distribution
Nationwide distribution to hospitals and medical device distributors.

Product description

BD Vacutainer Urine Complete Kit with UA Preservative Tube and C&S Preservative Tube for Midstream Specimens PLUS Plastic, Sterile Cup and Tube Interiors. Store at 4-25 degrees C. For In Vitro Diagnostic Use. Becton Dickinson and Company, Franklin Lakes, NJ.

Code information (models, lots, serial numbers)

Catalog # 364957, lot number 9125262, Exp. 11/2010

Other devices under the same FDA submission

4 devices cleared under K024240 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 53650).

Sources and updates

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