Z-0088-2024 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 Portacath Pack, Cat. SANV1PIFSB, Medstar Franklin Square Med CE, Sterile; and (2) Presource Bone Marrow Harvest Pack, Cat. SAN12BHGT1, Medstar Georgtown University H, 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. SANV1PIFSB - Lot #67711, Exp. 3/1/2026, UDI-DI 10195594532048; and (2) Cat. SAN12BHGT1 - Lot #13526, Exp. 3/1/2024, UDI-DI 10197106202715.