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U.S. Department of Health and Human Services

Class 2 Device Recall Integra Small Rickham Style Reservoir

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 Class 2 Device Recall Integra Small Rickham Style Reservoirsee related information
Date Initiated by FirmNovember 13, 2013
Date PostedJanuary 03, 2014
Recall Status1 Terminated 3 on February 13, 2015
Recall NumberZ-0621-2014
Recall Event ID 67025
Product Classification Shunt, central nervous system and components - Product Code JXG
ProductIntegra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1121 Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining CSF (cerebral spinal fluid_ samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The reservoir provides easy access to the lateral ventricles and to cystic tumors for the injections of chemotherapeutic agents and/or radio-isotopes. The rickham reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart of the peritoneum.
Code Information 1091271, 1094671, 1104165, 1104631, 1104813, 1110404, 1120638, 1120816, 1122316, 1123940, 11311659, 1132989, 1133427
FEI Number 3003418325
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact
855-532-1723
Manufacturer Reason
for Recall		Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent or broken connectors that were shipped in sleeve-type package were found prior to use but after the sterile package was open
FDA Determined
Cause 2		Packaging
ActionIntegra sent an Urgent Voluntary Medical Device Recall letter dated November 13, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory for the affected product and if located stop using immediately. Customers were asked to complete the attached form and return it to Integra as indicated and keep a copy of the form for their records. Once the form was received by Integra they will send an RMA number, directions to return the product, and input an order to replace the quantity they indicated on the form. Customers with questions were instructed to call 1-855-532-1723. For questions regarding this recall call 855-532-1723.
Quantity in Commerce194 packages
DistributionWorldwide Distribution - USA including FL, NE, WI, WA, CT, ND, AL, NY, NH, OR, OK, MN, and TX. Internationally to Belgium, Czech Republic, Germany, France, Great Britian, Italy, Poland, and Portugal.
Total Product Life CycleTPLC 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.
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