Z-0086-2024 Class II Ongoing
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 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.
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. 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.