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Baxter 60'' Micro-Volume Extension Set, catalog 2N3350 recallZ-0521-03 · Baxter Healthcare Corp. · initiated Oct 17, 2002

Terminated All recalls posted in February 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 Baxter Healthcare Corp. 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 I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.

FDA root cause category: Other

What the company is doing

Recalled by letter dated 10/17/02. Accounts were informed of the potential for the filters to be 1.2 micron filters instead of the 0.22. micron filters as labeled. The accounts were requested to examine their inventories for the affected catalog numbers and destroy the units found for credit.

Recall details

Recall number
Z-0521-03
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 17, 2002
Posted by the FDA
Feb 6, 2003
Recalling firm
Baxter Healthcare Corp.
Quantity
630,140 units
Product code
FPA
FDA submissions
K791496, K860746
Distribution
Nationwide, Australia, Puerto Rico, Brazil, Canada, Sweden, New Zealand, Japan, Mexico, American Samoa, El Salvador, Turkey, Saudi Arabia, Austria, Cayman Islands, Macedonia, Honduras, Kuwait, Hong Kong and Nigeria.

Product description

Baxter 60'' Micro-Volume Extension Set, catalog 2N3350; Baxter Healthcare Corporation, Deerfield, IL 60015

Code information (models, lots, serial numbers)

All lots received prior to 10/23/2002

Other devices under the same FDA submission

1 device cleared under K791496, K860746 — 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 25088).

Sources and updates

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