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BD Vacutainer Safety-Lok Blood Collection Set with… recallZ-0777-2007 · Becton Dickinson & Company · initiated Mar 20, 2007

Terminated All recalls posted in May 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

The BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder has a problem where the non-patient needle (in the holder) may become separated from the hub and remain the stopper of an evacuated blood collection tube.

FDA root cause category: Other

What the company is doing

Recall letters were sent to customers on 3/11/2007 via a third party, West Inc., Appleton, WI who will coordinate the mailing to all consignees.

Recall details

Recall number
Z-0777-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 20, 2007
Posted by the FDA
May 10, 2007
Recalling firm
Becton Dickinson & Company
Quantity
147,200 units
Product code
JKA
FDA submissions
K980414
Distribution
Nationwide and Canada.

Product description

BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder. Color green. 21 Gauge. Translucent, integrated protective shield that provides one-handed activation immediately after use, 0.75 in needle length, 12 in tubing, Luer adapter and holder, wings, sterile.

Code information (models, lots, serial numbers)

Catalog # 368652 Lot Numbers: 5236082; 5236093; 5236095.

Other devices under the same FDA submission

1 device cleared under K980414 — 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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