FDA-Device2023-10-18Class II

Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.

Cardinal Health 200, LLC
Hazard

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

Sold states
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.
Affected count
13,351 total packs
Manufactured in
3651 Birchwood Dr, N/A, Waukegan, IL, United States
Products
Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0090-2024

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