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Y-Type Blood/Solution Set, catalog #1C8372 recallZ-0450-03 · Baxter Healthcare Corp. · initiated Dec 18, 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 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

Leakage may occur at the inlet port

FDA root cause category: Other

What the company is doing

The affected product codes and lot numbers were recalled by letter dated 12/18/02. The customers were informed of the potential leakage at the inlet port, and were requested to inspect their inventory for the affected products and destroy those found. The accounts were requested to complete the enclosed reply form and certificate of destruction and return them to Baxter for credit issuance.

Recall details

Recall number
Z-0450-03
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 18, 2002
Posted by the FDA
Jan 16, 2003
Recalling firm
Baxter Healthcare Corp.
Quantity
42,330 sets
Product code
KSB
FDA submissions
K925126
Distribution
Nationwide

Product description

Y-Type Blood/Solution Set, catalog #1C8372; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, 2 Injection Sites, Male Luer Lock Adapter, 111'' long, 10 drops per mL; Baxter Healthcare Corporation, Deerfield, IL 60015

Code information (models, lots, serial numbers)

lots GR183152, GR183483, GR184622, GR185652

Other devices under the same FDA submission

4 devices cleared under K925126 — 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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