Cardinal Health 200, LLC: Medical Device Recall in 2023 - (Recall #: Z-0086-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.
Product Description:

Procedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (2) Presource PBDS Cat. PG33BTO22, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (3) Presource PBDS Cat. PG33SROUB, Ohio State Univ Wexner Med Ctr, Kit, Robot Surg Onc, Sterile; (4) Presource PBDS Cat. PUMHCCESP, Southeast Hospital MHHS, Kit, Cystoscopy, SE, Sterile; (5) Presource General Laparoscopy Pack, Cat. SBA18GLEFF, St. Elizabeth Medical Center, Sterile; (6) Presource IUS Perc 1 Pk, Cat. SOTCGPPMEA, IU Health Methodist Hospital, Sterile; (7) Presource Cysto Pack, Cat. SOT18CYEFC, St. Elizabeth Medical Center; Sterile (8) Presource GU PUP Pack, Cat. SOT29GUHCD, Hillcrest Hospital, Sterile; (9) Presource PCNL Pack, Cat. SOT30PENBB, North Bay Regional Hlth Ctr, Sterile; (10) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO13, Ohio State Univ Wexner Med Ctr., Sterile; (11) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO15, Ohio State Univ Wexner Med Ctr., Sterile; (12) Presource PNL Cysto Pack, Cat. SOT51CPKOA, KP Oakland Med Center, Sterile; (13) Presource PNL Cysto Pack, Cat. SOT51CPK10, KP Oakland Med Center, Sterile; (14) Presource PCN Pack, Cat. SOT69PCKSA, KP Los Angeles Med Center, Sterile; (15) Presource Perc Neph Pack, Cat. SOT7APNLVB, Lehigh Valley Hospital, Sterile; and (16) Presource Cysto Pack, Cat. SOT73CPKSB, KP Zion Med Cntr, Sterile.

Product Classification:

Class II

Date Initiated: August 16, 2023
Date Posted: October 18, 2023
Recall Number: Z-0086-2024
Event ID: 92875
Reason for Recall:

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

Status: Ongoing
Product Quantity: 13,351 total packs
Code Information:

(1) Cat. PG33BTO21 - Lot #914590, Exp. 6/1/2024, UDI-DI 10195594884130; (2) Cat. PG33BTO22 - Lot #928313, Exp. 2/1/2024, UDI-DI 10197106010419; (3) Cat. PG33SROUB - Lot #81580, Exp. 12/1/2024, UDI-DI 10197106186930; (4) Cat. PUMHCCESP - Lot #4316, Exp. 2/1/2025 and 9/1/2025, UDI-DI 10195594542153; (5) Cat. SBA18GLEFF - Lot #895495, Exp. 6/1/2025 and Exp. 7/1/2025, UDI-DI 10888439910209; (6) Cat. SOTCGPPMEA - Lot #984246, Exp. 7/1/2025 and Exp. 5/1/2024, UDI-DI 10888439847475; (7) Cat. SOT18CYEFC - Lot #928044, Exp. 4/1/2027, UDI-DI 10888439910216; (8) Cat. SOT29GUHCD - Lot #986052, Exp. 6/1/2027, UDI-DI 10195594963811; (9) Cat. SOT30PENBB - Lot #987163, Exp. 8/1/2025, UDI-DI 10888439948707; (10) Cat. SOT33PNO13 - Lot #920956, Exp. 8/1/2024, UDI-DI 10195594887452; (11) Cat. SOT33PNO15 - Lot #966904, Exp. 6/1/2024, UDI-DI 10197106087619; (12) Cat. SOT51CPKOA - Lot #916606, Exp. 11/1/2023, UDI-DI 10887488777795; (13) Cat. SOT51CPK10 - Lot #997330, Exp. 2/1/2024, UDI-DI 10197106161418; (14) Cat. SOT69PCKSA - Lot #997386, Exp. 3/1/2024, UDI-DI 10888439898071; (15) Cat. SOT7APNLVB - Lot #930337, Exp. 5/1/2024, UDI-DI 10888439925708; and (16) Cat. SOT73CPKSB - Lot #923138 Exp. 1/1/2025, UDI-DI 10888439906561.

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.

Voluntary or Mandated:

Voluntary: Firm initiated