Device product
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.
Z-0088-2024
Product summary
- Event
- Event 92875
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 13,351 total packs
- Official record key
device-enforcement:Z-0088-2024
Official wording
Reason: Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
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.
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
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).