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Recall Observatory FDA recall evidence

Device product

SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use in patient/healthcare personnel interactions. AAMI Level II isolation gowns are intended for relatively low risk procedures, including blood draws, lab work, or similar.

Z-0281-2021

August 13, 2020

Class II

Product summary

Firm
Sobel Westex
Event
Event 86351
Status
Terminated
Classification
Class II
Quantity
3,380,850 gowns
Official record key
device-enforcement:Z-0281-2021

Official wording

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

Code information: Catalog: HGCR4958.45D-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)

Distribution pattern: U.S. Nationwide distribution including in the state of TN. O.U.S.: None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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