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U.S. Department of Health and Human Services

Class 2 Device Recall POWERWAND Safety Introducer with Extended Dwell Catheter

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 Class 2 Recall
POWERWAND Safety Introducer with Extended Dwell Catheter
see related information
Date Posted September 18, 2013
Recall Status1 Terminated on September 24, 2013
Recall Number Z-2254-2013
Recall Event ID 66223
Premarket Notification
510(K) Numbers
K111417  K121748  K131300 
Product Classification Introducer, Catheter - Product Code DYB
Product 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.
Code Information Lot no. I666473
Recalling Firm/
Manufacturer
Access Scientific Inc
3910 Sorrento Valley Blvd Ste 200
San Diego, California 92121-1419
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Phil Royston
858-259-8333
Manufacturer Reason
for Recall
Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control
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.".
Quantity in Commerce 160 units
Distribution Distributed in MI and TX.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = ACCESS SCIENTIFIC, INC.
510(K)s with Product Code = DYB and Original Applicant = ACCESS SCIENTIFIC, LLC
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