FDA Medical Device Recalls (openFDA)
Hamilton Co: Y-valve and T-valve, PSD/4 Syringe Drive Module parts.
- Recall number
- Z-0087-06
- Recalling firm
- Hamilton Co
- Product
- Y-valve and T-valve, PSD/4 Syringe Drive Module parts.
- Status
- Terminated
- Initiated
- 2005-08-24
- Posted
- 2005-10-22
- Terminated
- 2006-03-24
- Reason
- The product valve has a high probability of deforming and may result in leakage during use.
- Root cause
- Other
- Action
- 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).
- Quantity
- 271 Y and 78 T valves were distributed.
- Distribution
- One distributor and 8 consumers received this product in CA, MA, MI, WI, Japan and Switzerland.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJC
- Firm FEI
- 2915796
- Firm city
- Reno
- Firm state
- NV
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28