Recall Z-0621-2014 ยท JXG Shunt, Central Nervous System And Components
Integra LifeSciences Corp.
Integra 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 ve
| Date | Jan 3, 2014 (initiated Nov 13, 2013) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Packaging |
| Action | Integra 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 q |
| Quantity | 194 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.