Device product
TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
Z-1033-2022
Product summary
- Event
- Event 89991
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1033-2022
Official wording
Reason: Potential breach in the sterility barrier for tray ring covers.
Code information: All Lots within Expiry: GTIN:05050474520707
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.
Derived failure modes
-
Unknown
Potential breach in the sterility barrier for tray ring covers.