Z-0090-2024 Class II Ongoing
FDA device recall Z-0090-2024 was initiated by Cardinal Health 200, LLC on Aug 16, 2023 and is designated Class II. Reason for recall: Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). The recall status is ongoing. Affected quantity: 13,351 total packs.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 18, 2023
- Initiation Date
- Aug 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,351 total packs
Product Description
Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.
Reason for Recall
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV. There was government distribution and no military distribution. The country of Canada.
Code Information
Lot #81461, Exp. 6/1/2024 and Exp. 9/1/2024, UDI-DI 10195594542795.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0090-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026