—#179978

Product

Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

FDA product code: OJK — Eye Tray
Device class: Class 2
Medical specialty: Ophthalmic
Affected lot / code info: Item Codes: ADCO026-17, SINA217. Lot Numbers: 1336261, 1361099, 1363225, 1367696, 1371095, 1374420, 1376394, 1383159. Expiration dates: 02/10/2020-11/18/2022.

Why it was recalled

The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.

Root cause (FDA determination)

Other

Action the firm took

URGENT MEDICAL DEVICE RECALL NOTICE letters, dated February 18, 2020, were distributed to customers. Letter provides identification of the issue, health risk and action to take. Customers were instructed to take the following required actions: " Review all storage and usage locations and segregate and quarantine any trays with an item code and lot number listed on attached Exhibit A. " Complete and return the enclosed Recall Response Form to Sharon.moll@owens-minor .com. Please respond even if you do not have any trays subject to this recall. " Upon receipt of your completed Recall Response Form, product return instructions will be provided and a RGA will be issued, if you do have trays subject to this recall. " If you have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this Urgent Medical Device Recall Notice . Your assistance is appreciated and necessary to prevent any unintended use of the product. If you have any questions, call Sharon Moll at 757-566-9844.

Recalling firm

Firm: Avid Medical, Inc.
Address: 9000 Westmont Dr, Toano, Virginia 23168-9351

Distribution

Distribution pattern: US: AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX WI, VA

Timeline

Recall initiated: 2020-02-18
Terminated: 2020-11-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179978. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.