Z-1033-2022 Class II Ongoing
FDA device recall Z-1033-2022 was initiated by Johnson & Johnson Surgical Vision Inc on April 6, 2022 and is designated Class II. Reason for recall: Potential breach in the sterility barrier for tray ring covers. The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- May 11, 2022
- Initiation Date
- April 6, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
Reason for Recall
Potential breach in the sterility barrier for tray ring covers.
Distribution Pattern
Worlwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, HI, IL, IN, KS, MA, MD, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OR, PA, TN, TX, WA, WI and the countries of Chile, Indonesia, India, Japan, Malaysia, Philippines, Taiwan.
Code Information
All Lots within Expiry: GTIN:05050474520707