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U.S. Department of Health and Human Services

Class 2 Device Recall InterPulse Handpiece Set With Suction Tubing

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  Class 2 Device Recall InterPulse Handpiece Set With Suction Tubing see related information
Date Initiated by Firm October 04, 2010
Date Posted January 25, 2011
Recall Status1 Terminated 3 on June 06, 2011
Recall Number Z-0947-2011
Recall Event ID 57470
510(K)Number K972069  
Product Classification Lavage, jet - Product Code FQH
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.

Code Information Part Number 0210-100-000 Lot Numbers 09362012 and 09362022 Expires 12/1/2011 
Recalling Firm/
Manufacturer
Stryker Instruments Division of Stryker Corporation
4100 East Milham Ave.
Kalamazoo MI 49001
For Additional Information Contact Angela Ragainis
800-800-4236 Ext. 4354
Manufacturer 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 2
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 in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FQH and Original Applicant = STRYKER INSTRUMENTS
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