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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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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
Distribution Pattern Distributed in MI and TX.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot no. I666473 Class II Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled. 160 units Z-2254-2013