Reported Jul 17, 2013 · Terminated

Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85"…

Baxter Healthcare Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Baxter Healthcare Corp. · 1 Baxter Pkwy · Deerfield, IL · 60015-4625

Is this the product you have?

  • Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2
  • m) UsageBaxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy, transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers
Lot codes and dates
  • 97 of 97 codes

    • UR175554
    • UR176743
    • UR182030
    • UR188144
    • UR192047
    • UR192096
    • UR192260
    • UR194951
    • UR202044
    • UR204032
    • UR211698
    • UR214312
    • UR216069
    • UR222471
    • UR225334
    • UR229294
    • UR233569
    • UR233700
    • UR238915
    • UR243022
    • UR246009
    • UR249383
    • UR255802
    • UR260273
    • UR262980
    • UR263004
    • UR265918
    • UR283580
    • UR287284
    • UR288746
    • UR298216
    • UR304246
    • UR307249
    • UR314328
    • UR318063
    • UR321000
    • UR325464
    • UR334151
    • UR339317
    • UR344234
    • UR352484
    • UR352567
    • UR360255
    • UR363432
    • UR366161
    • UR375857
    • UR383794
    • UR385534
    • UR07J19029
    • UR07K29059
    • UR07L21039
    • UR08B21053
    • UR08C25151
    • UR08E15157
    • UR08G22167
    • UR08I12065
    • UR08K13086
    • UR08L18158
    • UR09A21211
    • UR09D02157
Amount recalled
356,728 units

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

  • Nationwide

Why it was recalled

A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 16, 2015 · Data as of Sep 19, 6:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.