Z-0083-2024 Class II Ongoing
FDA device recall Z-0083-2024 was initiated by Cardinal Health 200, LLC on August 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
- October 18, 2023
- Initiation Date
- August 16, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,351 total packs
Product Description
Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block Tray, Catalog SNE37ANMOF, Medical Center Odessa.
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
(1) Cat. SBAHFPTAS2 - Lot #900813, exp. 1/1/2025, UDI-DI 10195594810351; and (2) Cat. SNE37ANMOF - Lot #32724, exp. 4/1/2025, UDI-DI 10195594576080.