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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 Device Recall POWERWAND Safety Introducer with Extended Dwell Cathetersee related information
Date Initiated by FirmAugust 16, 2013
Date PostedSeptember 18, 2013
Recall Status1 Terminated 3 on September 24, 2013
Recall NumberZ-2254-2013
Recall Event ID 66223
510(K)NumberK111417 K121748 K131300 
Product Classification Introducer, catheter - Product Code DYB
ProductPOWERWAND 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 CA 92121-1419
For Additional Information ContactPhil 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		Labeling Change Control
ActionOn 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 Commerce160 units
DistributionDistributed in MI and TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DYB
510(K)s with Product Code = DYB
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