PlainRecalls
FDA Devices Moderate Class II Terminated

Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1132 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

Reported: January 15, 2014 Initiated: November 13, 2013 #Z-0622-2014

Product Description

Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1132 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.

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 packages were found prior to use but after the sterile package was open.

Details

Units Affected
78 packages
Distribution
Worldwide 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.
Location
Plainsboro, NJ

Frequently Asked Questions

What product was recalled? ▼
Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1132 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.. Recalled by Integra LifeSciences Corp.. Units affected: 78 packages.
Why was this product recalled? ▼
Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent or broken connectors that were shipped in sleeve-type packages were found prior to use but after the sterile package was open.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 15, 2014. Severity: Moderate. Recall number: Z-0622-2014.

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