Reported May 1, 2013 · Terminated

Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile urine collection device that collects urine by…

Teleflex Medical

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: Teleflex Medical · 4024 Stirrup Creek Dr · Durham, NC · 27703-9000

Is this the product you have?

  • Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile urine collection device that collects urine by mechanical means when attached to an indwelling Foley or suprapubic catheter.
Lot codes and dates
  • 424 of 424 codes

    • CATALOG NO. B1000 - 02A1100488
    • 02A1100489
    • 02A1100490
    • 02A1100491
    • 02A1100492
    • 02A1101420
    • 02A1101421
    • 02A1102009
    • 02A1102010
    • 02A1102049
    • 02A1102050
    • 02A1103180
    • 02A1103181
    • 02A1103182
    • 02A1201862
    • 02A1201868
    • 02A1201869
    • 02A1201870
    • 02A1201871
    • 02A1202372
    • 02A1202373
    • 02A1202374
    • 02A1202376
    • 02A1202377
    • 02A1202378
    • 02A1202603
    • 02A1202632
    • 02A1202633
    • 02A1202634
    • 02A1202783
    • 02A1202784
    • 02A1202785
    • 02A1202786
    • 02A1202787
    • 02A1202788
    • 02A1202789
    • 02A1202790
    • 02A1202791
    • 02A1202792
    • 02A1203552
    • 02A1203553
    • 02A1203554
    • 02A1203555
    • 02A1203556
    • 02A1204179
    • 02B1100522
    • 02B1100523
    • 02B1100524
    • 02B1101000
    • 02B1101001
    • 02B1101002
    • 02B1102328
    • 02B1102329
    • 02B1103007
    • 02B1200105
    • 02B1200106
    • 02B1200107
    • 02B1201685
    • 02B1201686 02B1201687
    • 02B1201688
Amount recalled
190,103

Why it was recalled

Sterile packaging may be compromised.

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 May 1, 2014 · Data as of Sep 19, 4:53 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.