The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of

FDA device recall Z-0949-2011 · posted 2011-01-25 · Terminated

Recall details

Recalling firm

Stryker Instruments Division of Stryker Corporation

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.

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.

Root cause

Packaging process control

Status

Terminated

Product code

FQH

Quantity affected

954

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.

Date initiated

2010-10-04

Date posted

2011-01-25

Date terminated

2011-06-06

Location

Kalamazoo, MI

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