Y-valve and T-valve, PSD/4 Syringe Drive Module parts.
This recall has been terminated (originally issued October 22, 2005).
- Company
- Hamilton Co
- Recall Initiated
- August 24, 2005
- Posted
- October 22, 2005
- Terminated
- March 24, 2006
- Recall Number
- Z-0087-06
- Quantity
- 271 Y and 78 T valves were distributed.
- Firm Location
- Reno, NV
- Official Source
- View on FDA website ↗
Reason for Recall
The product valve has a high probability of deforming and may result in leakage during use.
Distribution
One distributor and 8 consumers received this product in CA, MA, MI, WI, Japan and Switzerland.
Lot / Code Info
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.
Root Cause
Other
Action Taken
Recall initiated on 08/24/2005. The firm issued notification to its consignees via overnight letter, and via e-mail for its distributor (Hamilton Bonaduz).