Reported Oct 28, 2020 · Terminated

SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use…

Sobel Westex

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: Sobel Westex · 2670 Western Ave · Las Vegas, NV · 89109-1112

Is this the product you have?

  • SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven
  • laminate with PE Film - Product Usageuse in patient/healthcare personnel interactions. AAMI Level II isolation gowns are intended for relatively low risk procedures, including blood draws, lab work, or similar
Lot codes and dates
  • CatalogHGCR4958.45D-C
  • Batch/Lot Numbers
    • - 20200405 (293
    • 250 gowns manufactured) - 20200425 (1
    • 054
    • 050 gowns manufactured) - 20200502 (60
    • 000 gowns manufactured) - 20200508 (2
    • 033
    • 550 gowns manufactured)
Amount recalled
3,380,850 gowns

Where it was sold

  • Nationwide
  • TN

Why it was recalled

Due to non-surgical isolation gowns not meeting all performance test requirements.

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

Want the full recall guide?

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 8, 2024 · Data as of Sep 19, 4:55 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.