Recall Z-0296-2021

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: Nonconforming Material/Component

Action taken

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.