Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 15, 2014
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
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Integra LifeSciences Corp. recalled Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra Neur… - a moderate-severity action.
Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra Neur… was recalled by Integra LifeSciences Corp. in January 15, 2014. Reason: Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent or broken con…. Check the official notice for the remedy. Verify recall #Z-0622-2014 with the FDA Devices before acting.
The recall
Integra LifeSciences Corp. issued this moderate-severity FDA Devices recall-Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent or broken con….
- Moderate
- severity level
- Class II
- classification
- January 15, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0622-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0622-2014) was formally reported on January 15, 2014, with the manufacturer initiating the action on November 13, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Integra LifeSciences Corp. is listed as the recalling firm, operating out of Plainsboro, NJ. Federal records list the affected scope as 78 packages.
The documented reason for this recall is: 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 op… Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
78 packages
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0622-2014 |
| Date reported | January 15, 2014 |
| Date initiated | November 13, 2013 |
| Recalling firm | Integra LifeSciences Corp. |
| Firm location | Plainsboro, NJ |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0622-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0622-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 15, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.