Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0090-2024

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-0090-2024

Official wording

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

Code information: Lot #81461, Exp. 6/1/2024 and Exp. 9/1/2024, UDI-DI 10195594542795.

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).