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Recall Observatory FDA recall evidence

Device product

TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,

Z-1033-2022

April 06, 2022

Class II

Product summary

Firm
Johnson & Johnson Surgical Vision Inc
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

    reason.no_named_rule · v1.0.0

    Potential breach in the sterility barrier for tray ring covers.