The Recall Desk
HighFDA (Devices)·Z-0621-2014·Announced 2014-01-15

Integra Small Rickham-Style Reservoirs Recalled for Bent or Broken Connectors

Integra LifeSciences is recalling 194 packages of Small Rickham-Style Reservoirs due to bent or broken connectors found after opening the sterile package.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural defect (bent/broken connectors) in a medical device used for invasive procedures, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Integra LifeSciences Corp. is recalling 194 packages of the Integra Small Rickham-Style Reservoir. 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 after the sterile package was opened but before the device was used.

The affected devices are sterile, single-use medical devices intended to provide access to the lateral cerebral ventricles via hypodermic puncture. They are used for obtaining cerebrospinal fluid samples, monitoring ventricular fluid pressure, ventricular drainage, and injecting chemotherapeutic agents or radio-isotopes. The recall includes specific lot codes: 1091271, 1094671, 1104165, 1104631, 1104813, 1110404, 1120638, 1120816, 1122316, 1123940, 11311659, 1132989, and 1133427.

The affected products were distributed worldwide, including in the United States (specifically FL, NE, WI, WA, CT, ND, AL, NY, NH, OR, OK, MN, and TX) and internationally to Belgium, the Czech Republic, Germany, France, Great Britain, Italy, Poland, and Portugal. Healthcare providers and patients should check their inventory for these specific lot codes and stop using any affected devices.

The recalled product

Product
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 C
Manufacturer
Integra LifeSciences Corp.
Category
Medical Device — Neurological / Ventricular Access
Hazard
Affected units
194

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 (13)

  • 1091271
  • 1094671
  • 1104165
  • 1104631
  • 1104813
  • 1110404
  • 1120638
  • 1120816
  • 1122316
  • 1123940
  • 11311659
  • 1132989
  • 1133427

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 · structural defect

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