The Recall Desk

FDA (Devices) recall action 67025

Integra LifeSciences Corp. recalled 2 products on 2014-01-15

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2014-01-15
Critical
0
Units
272

Why these products were recalled

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

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    13 states
  • ModerateFDA (Devices)··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.

    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
    Category
    Distribution
    13 states