FDAFDA · Food and drugs·Recall number Z-1033-2022
TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
Published May 11, 2022 · Recall initiated: April 6, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential breach in the sterility barrier for tray ring covers.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Johnson & Johnson Surgical Vision Inc
- Distributor
- 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.
- Lot
- All Lots within Expiry: GTIN:05050474520707
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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