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Recall Observatory FDA recall evidence

Device product

Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block Tray, Catalog SNE37ANMOF, Medical Center Odessa.

Z-0083-2024

August 16, 2023

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 92875
Status
Ongoing
Classification
Class II
Quantity
13,351 total packs
Official record key
device-enforcement:Z-0083-2024

Official wording

Reason: Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).