Z-1967-2012Class II

Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081

Name: Z-1967-2012 Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081
Creator: Edwards Lifesciences, LLC
Published: 2012-06-06
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2012-06-06 / Terminated / root cause: manufacturing process

FDA source

Edwards Lifesciences, LLC began a recall of Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to remove fluid on... on 2012-06-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1967-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-06
Posted: 2012-07-09
Terminated: 2012-09-10
Recalling firm: Edwards Lifesciences LLC
Product: Edwards 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.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1967-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1967-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-09

Product code DWF

K831759Class IIIntracardia SuckersResearch Industries Corp. / cleared 1983-08-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)