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U.S. Department of Health and Human Services

Enforcement Report - Week of August 22, 2012

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Event Detail

Event ID 62588
Product Type Devices
Status Ongoing
Recalling Firm Nico Corp.
City Indianapolis
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-17
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - USA including MI and Canada

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues. REF: NN-8011 - LOT: 80344-TD00214 (manufactured on 11-April-2012) Class II BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label does not match the actual length of the sheath within the packaging resulting in an improper fit as further explained below. This mislabeling was discovered on 29-June-2012 during a clinical case. 20 devices (4 boxes, 5 devices per box) Z-2200-2012
13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues. REF: NN-8012 - LOT: 80345-TD00214 (manufactured on 11-April-2012) Class II BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label does not match the actual length of the sheath within the packaging resulting in an improper fit as further explained below. This mislabeling was discovered on 29-June-2012 during a clinical case. 15 devices (3 boxes, 5 devices per box) Z-2201-2012
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