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Clearlink System Vented Paclitaxel Set, 10 drops/mL, 111''… recallZ-1158-03 · Baxter Healthcare Corp. · initiated Jul 16, 2003

Terminated All recalls posted in August 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

There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.

FDA root cause category: Other

What the company is doing

Recalled by letter dated 7/16/03. The accounts were informed of the potential for leaks in the set tubing, and asked to inspect their inventory for the affected product codes and lots, segregate any affected products found and discard them according to local procedures. The customers will receive credit for the discarded affected product.

Recall details

Recall number
Z-1158-03
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jul 16, 2003
Posted by the FDA
Aug 21, 2003
Recalling firm
Baxter Healthcare Corp.
Quantity
11,280 units
Product code
FPA
FDA submissions
K981792, K003225
Distribution
Nationwide, Mexico, Canada, Columbia, Australia, New Zealand and Taiwan

Product description

Clearlink System Vented Paclitaxel Set, 10 drops/mL, 111'', Polyethylene Lined Tubing, Non-DEHP Pump Segment, 0.22 Micron Extended Life Filter, Luer Activated Valve, Male Luer Lock Adapter, catalog 2C8857; Baxter Healthcare Corporation, Deerfield, IL 60015 USA

Code information (models, lots, serial numbers)

catalog 2C8857, lot numbers UR134353 through UR157545. Please note: Baxter lot numbers are represented by an internal reference code ''UR'' followed by a six digit sequential number, or by the letter ''U'' followed by a six digit sequential number with and ''R'' suffix. Any lot number appearing within the identified six digit sequential number range is subject to the recall.

Other devices under the same FDA submission

4 devices cleared under K981792, K003225 — 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 26772).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page