Recall Z-0947-2011
Stryker Instruments Division of Stryker Corporation · initiated October 4, 2010
Product
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 includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds.
Codes / lots: Part Number 0210-100-000 Lot Numbers 09362012 and 09362022 Expires 12/1/2011
Reason for recall
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.
FDA-determined cause: Packaging process control
Action taken
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.
Details
- Recall number
- Z-0947-2011
- Initiated
- October 4, 2010
- Posted by FDA
- January 25, 2011
- Terminated
- June 6, 2011
- Product code
- FQH – Lavage, Jet
- Quantity
- 490
- 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.
- Recalling firm
- Stryker Instruments Division of Stryker Corporation, Kalamazoo, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0948-2011 | The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed…There is potential for a breach in sterility in the blister packaging. This can lead to the use of… | 10/04/2010Terminated |
| Z-0949-2011 | The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed…There is potential for a breach in sterility in the blister packaging. This can lead to the use of… | 10/04/2010Terminated |
| Z-0950-2011 | The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed…There is potential for a breach in sterility in the blister packaging. This can lead to the use of… | 10/04/2010Terminated |
| Z-0951-2011 | The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed…There is potential for a breach in sterility in the blister packaging. This can lead to the use of… | 10/04/2010Terminated |
| Z-0952-2011 | The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed…There is potential for a breach in sterility in the blister packaging. This can lead to the use of… | 10/04/2010Terminated |
| Z-0953-2011 | The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed…There is potential for a breach in sterility in the blister packaging. This can lead to the use of… | 10/04/2010Terminated |