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U.S. Department of Health and Human Services

Class 2 Device Recall Laws of Motion

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  Class 2 Device Recall Laws of Motion see related information
Date Initiated by Firm September 17, 2020
Create Date October 26, 2020
Recall Status1 Open3, Classified
Recall Number Z-0296-2021
Recall Event ID 86431
Product Classification Gown, surgical - Product Code FYA
Product LOM Disposable Surgical Gowns/Medical Gowns, Single-Use
Code Information Lots 1 -47
Recalling Firm/
Manufacturer		 THREAD COUNSEL INC DBA LAWS OF MOTION
175 Varick St
New York NY 10014-4604
For Additional Information Contact Lynn A. Neils
212-408-2510
Manufacturer Reason
for Recall		 Medical gowns distributed to customers did not include appropriate labeling, and some gowns may not meet FDA's standards for surgical gowns.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On September 17, 2020, the firm sent an Urgent Medical Device Recall letter to New York State. The customer was informed of the product deficiencies. The customer was asked to take the following actions: 1. Immediately identify and quarantine all Affected Gowns at your site. As per the FDA Release, dated August 28, 2020, medical personnel should not use or further distribute LOMs gowns until the FDA completes its investigation (Attachment A). Therefore, do not distribute or use the Affected Gowns. 2. Complete the attached Return Recall Response Form to confirm the number of Affected Gowns remaining in your inventory, as well as the status of the remaining 505,220 gowns (Remaining Gowns) which are no longer in your possession (i.e., where they were distributed, if they were used, etc.). Please send the completed form by email to Marissa Custren, Head of Logistics, Laws of Motion PPE at ppe@lawsofmotion.com or fax it to the attention of Lynn Neils, Esq. at Baker Botts LLP at (212) 259-2510. 3. Upon receiving the completed Response Form, we will contact you to arrange for the return of the Affected Gowns. You may also contact outside counsel, Drew Chapman (212) 408- 2515, or Lynn Neils, (212) 408-2510, with Baker Botts LLP, to arrange for delivery or pick-up of the Affected Gowns. 4. Notify all customers/medical facilities/providers who may have received this product of this recall. Alternately, you may provide LOM with a list of your customers and LOM will notify these accounts on your behalf. 5. Ensure that all impacted employees at your site have been informed of this recall.
Quantity in Commerce 2.4 million
Distribution Distributed to accounts in New York
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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