Device Recall PSD/4 Syringe Drive module

  • Model / Serial
    catalog number 7427-01 (Y-valve), catalog number 7990-01 (T-valve), catalog number 51863-01-IL (PSD/4 with valve and syringe), no 510k number.  For 7427-01 (Lot number, date of manufacture): 277702, 4/29/2003; 282550A, 8/11/2003; 282550, 8/13/2003; 286630, 10/1/2003; 287449, 10/20/2003; 287137, 10/20/2003; 287949, 12/18/2003; 301809, 6/30/2004; 305599, 8/19/2005; 309328, 11/5/2004; 313276, 12/17/2004; 314662, 3/7/2005; 317940, 4/6/2005; 319506, 4/11/2005; 321121, 5/6/2005; 324204, 6/23/2005; 325483, 7/20/2005.  For 7990-01: 277703, 4/30/2003; 283119, 9/30/2003 291279, 1/7/2004; 303942, 7/19/2004; 303687, 7/19/2004; 318833, 3/24/2005; 319684, 5/5/2005.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    One distributor and 8 consumers received this product in CA, MA, MI, WI, Japan and Switzerland.
  • Product Description
    Y-valve and T-valve, PSD/4 Syringe Drive Module parts.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Hamilton Co, 4970 Energy Way, Reno NV 89502-4123
  • Source
    USFDA