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U.S. Department of Health and Human Services

Class 2 Device Recall Rigid Suction Wand

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 Class 2 Device Recall Rigid Suction Wandsee related information
Date Initiated by FirmJune 06, 2012
Date PostedJuly 09, 2012
Recall Status1 Terminated 3 on September 10, 2012
Recall NumberZ-1967-2012
Recall Event ID 52194
510(K)NumberK831759 
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
ProductEdwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular involvement.
Code Information Lot numbers: 58749813, 58802303, 58836847, 58877405, 58909346, 59011910, 59035360, 59085935, 59118391, 59241531, 58705682, 58711964, 58722234, 58771175, 58837337, 58855247, 58904182, 58927518, 58936037, 58936014, 58936027, 59009635, 59030253, 59056470, 59103213, 59124020, 59199172, 59218725, 59235997.
Recalling Firm/
Manufacturer		 Edwards Lifesciences, LLC
12050 Lone Peak Pkwy
Draper UT 84020-9414
For Additional Information Contact
801-565-6100
Manufacturer Reason
for Recall		Edwards is recalling Suction Wand models SPC2081 and S033 because the plastic tip attached to the metal suction wand may become detached during routine use.
FDA Determined
Cause 2		Process control
ActionEdwards Lifesciences sent an Urgent Field Safety Notice Product Recall letter dated June 2012 to all affected customers. The letter identified the affected product, description of the issue and actions to be taken. Customers were instructed to examine their inventory for the affected product, quarantine and return any remaining in stock and complete the enclosed acknowledgment form with fax instructions to assure that the notification was received. For question call Edwards Customer Service at (800) 424-3278 from 8:00AM-4:30PM Pacific Time.
Quantity in Commerce1524 units
DistributionWorldwide Distribution - US (nationwide) including the states of CT, TX, CA, AZ, MO, and MD and the countries of Europe and Japan.
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 = DWF
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