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U.S. Department of Health and Human Services

Class 2 Device Recall SOBEL WESTEX Disposable Isolation Gown

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 Class 2 Device Recall SOBEL WESTEX Disposable Isolation Gownsee related information
Date Initiated by FirmAugust 13, 2020
Create DateOctober 22, 2020
Recall Status1 Terminated 3 on July 08, 2024
Recall NumberZ-0281-2021
Recall Event ID 86351
Product Classification Non-surgical isolation gown - Product Code OEA
ProductSOBEL 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.
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)
Recalling Firm/
Manufacturer		 Sobel Westex
2670 Western Ave
Las Vegas NV 89109-1112
For Additional Information ContactStan Levithan
516-792-2152
Manufacturer Reason
for Recall		Due to non-surgical isolation gowns not meeting all performance test requirements.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionCustomer Notification Letters titled "Voluntary Market Withdrawal - Customer Notification - SW-CMP0001" was sent out on 08/13/2020, 08/14/2020 and 08/25/2020 via email and telephone to a customer informing them that the Recalling Firm has become aware of non-surgical gowns labeled as Level 2 gowns do not meet the Level 2 requirements in one area of the gown. The Recalling Firm is instructing customers to: 1. Return any remaining affected gowns for a refund of the original purchase price, or 2. Return any remaining affected gowns and receive replacement of certified AAMI Level 2 isolated gowns at the Recalling Firm's expense. Customer are to contact Stan Levithan at 516-792-2152 to facilitate return and/or exchange of affected gowns.
Quantity in Commerce3,380,850 gowns
DistributionU.S. Nationwide distribution including in the state of TN. O.U.S.: None
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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