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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Detail

Product Description POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the vascular system to sample blood and administer fluids intravenously.
Recall Number Z-2254-2013
Classification Class II
Code Info Lot no. I666473
Product Distributed Qty 160 units
Reason For Recall Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled.

Event Detail

Event Id 66223
Product Type Devices
Status Completed
Recalling Firm Access Scientific Inc
City San Diego
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-16
Initial Firm Notification of Consignee or Public Visit
Distribution Pattern Distributed in MI and TX.
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