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Terminated

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.

FDA Recall Z-2254-2013 · Posted 2013-09-18

Recalling FirmAccess Scientific Inc
Recall StatusTerminated
Product CodeDYB
Date Initiated2013-08-16
Date Terminated2013-09-24
Product Quantity160 units

Reason for Recall

Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled.

Firm Action

On 8/16/13, Access Scientific visited 2 consignees and initiated a field correction. This is the communication given to the two(2) accounts by our field personnel: "Access Scientific has inadvertently shipped mislabeled devices to your facility. The products affected were 5 Fr. POWERWANDs, Catalog # 92006, lot # I666473." The consignees were instructed to "Quarantine the devices until Access Scientific personnel arrived with the appropriate labeling and performed the corrective action of applying the correct labels to the devices and inserting the DFU into the boxes."

Root Cause

Labeling Change Control

Distribution Pattern

Distributed in MI and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K131300THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETERAccess Scientific, LLC · 2013-06-07K121748THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELLAccess Scientific, Inc. · 2012-07-27K111417THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETERAccess Scientific, Inc. · 2011-07-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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