Recall Z-0034-06 ยท LXC Monitor, Pressure, Intracompartmental
Stryker Instruments Div. of Stryker Corporation
Stryker brand Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000.
| Date | Oct 12, 2005 (initiated Jul 22, 2005) |
| Status | Terminated |
| Reason | The pressure indicated may be inaccurate, and this inaccuracy may be not detectable by the user. |
| Root cause | Other |
| Action | Consignees were notified by recall letter dated August 5, 2005 to locate the affected serial numbers and to return the product to the firm. |
| Quantity | 473 |
| Distribution | Nationwide, Argentina, Australia, Canada, Costa Rica, England, France, Germany, Hong Kong, India, Indonesia, Japan, Netherlands, New Zealand, South Africa, Spain, Sweden, Switzerland, Taipei, Turkey and United Arab Emir. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K844214 | COMPARTMENT SYNDROME PRESSURE MONITOR SYS Stryker Corp., Apr 4, 1985 |