Recall Z-0953-2011 ยท FQH Lavage, Jet
Stryker Instruments Division of Stryker Corporation
The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This
| Date | Jan 25, 2011 (initiated Oct 4, 2010) |
| Status | Terminated |
| Reason | There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection. |
| Root cause | Packaging process control |
| Action | Stryker sent a Medical Device Recall Notification letter dated October 8, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to destroy and dispose of all affected product and to complete the business reply form and return to Stryker to receive replacement interpulse products at no charge. For questions regarding this recall call (269) 323-7700. |
| Quantity | 103 |
| Distribution | Worldwide Distribution - USA (including all 50 states) and the countries of Brazil, Canada, France, Germany, Japan, Netherlands, South Africa, South Korea, Spain, Sweden, Switzerland and the UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972069 | STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK Stryker Instruments, Jul 29, 1997 |