The Recall Desk
ModerateFDA (Devices)·Z-0622-2014·Announced 2014-01-15

Integra Rickham Reservoirs Recalled for Bent or Broken Connectors

Integra LifeSciences is recalling 78 packages of Rickham-Style Reservoirs due to bent or broken connectors found after opening sterile packages.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the defects were detected prior to use, representing a low-risk contamination or defect scenario without reported injuries.

Plain-English summary

Integra LifeSciences Corp. is recalling 78 packages of Integra Large Rickham-Style Reservoirs. The recall was initiated after the company identified an adverse complaint trend indicating that some reservoirs had bent or broken connectors. These defects were discovered prior to use but after the sterile package had been opened.

The affected products are sterile, single-use medical devices intended to provide access to the lateral cerebral ventricles for obtaining cerebrospinal fluid samples, monitoring pressure, or administering agents. The recall covers units shipped in sleeve-type packages.

The affected products were distributed worldwide, including in the United States and several international locations. Patients and healthcare providers who have received these specific devices should contact their healthcare provider or the manufacturer for instructions on how to proceed.

The recalled product

Product
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 C
Manufacturer
Integra LifeSciences Corp.
Category
Medical Device — Neurological
Hazard
Affected units
78

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • 1094085
  • 1101479
  • 1101647
  • 1102403
  • 1102807
  • 1104174
  • 1110043
  • 1120817
  • 1130797
  • 1131331
  • 1131660

Distribution

Distributed in 13 states:

Part of a larger recall action

This product is one of 2 recalled by Integra LifeSciences Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Integra LifeSciences Corp.

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Same hazard · defective connector

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