TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
Check against the official notice below — it lists the full affected range.
Johnson & Johnson Surgical Vision Inc. is recalling tray ring covers (model OM271000) distributed worldwide because of a potential breach in the sterility barrier. The affected product was distributed nationwide across 28 U.S. states and also to Chile, Indonesia, India, Japan, Malaysia, Philippines, and Taiwan. All lots within the product's expiration date with GTIN 05050474520707 are included in this recall.
The sterile tray ring covers are prescription medical devices used in surgical procedures. A breach in the sterility barrier could compromise the product's ability to maintain sterile conditions. The recall notice does not specify a remedy for consumers who have obtained this product.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential breach in the sterility barrier for tray ring covers.
Reason for recall: Potential breach in the sterility barrier for tray ring covers. Distribution: 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. Quantity: N/A Lot/code info: All Lots within Expiry: GTIN:05050474520707
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.