FDA recall Z-1033-2022

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2022-04-06

Report date

2022-05-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Santa Ana, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1033-2022