Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters
FDA device recall Z-1967-2012 · posted 2012-07-09 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences, LLC
- 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.
- Action taken
- Edwards 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 1524 units
- Distribution
- Worldwide Distribution - US (nationwide) including the states of CT, TX, CA, AZ, MO, and MD and the countries of Europe and Japan.
- Date initiated
- 2012-06-06
- Date posted
- 2012-07-09
- Date terminated
- 2012-09-10
- Location
- Draper, UT
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| INTRACARDIA SUCKERS (K831759) | Research Industries Corp. | 1983-08-12 |