Z-1749-2013Class II

Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and...

Name: Z-1749-2013 Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and...
Creator: Edwards Lifesciences, LLC
Published: 2013-06-19
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2013-06-19 / Terminated / root cause: design

FDA source

Edwards Lifesciences, LLC began a recall of Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in... on 2013-06-19. FDA classified it as Class II and gives the reason as "Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particulate inside the sterile pouch and within the internal diam ether of the wand". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1749-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-19
Posted: 2013-07-17
Terminated: 2014-11-04
Recalling firm: Edwards Lifesciences LLC
Product: Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particulate inside the sterile pouch and within the internal diam ether of the wand.
Root cause tag: design
FDA root cause: Component design/selection
Action: Edwards sent an Urgent Field Safety Notice Product Recall letter, dated June 19, 2013, via FedEx to all affected customers. Two additional attempts will be made to notify customers to return products. The letter idenditifed the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory for any affected device in their inventory, quarantine all affected product from their inventory and return all devices to Edwards. Customers were instructed to acknowledge that they have reviewed the Recall Notice and confirm that they have taken appropriate action by completing, sign and dating the enclosed Recall Response Form and returning the form to Edwards by fax to Edwards Customer Service at 800-422-9329. Customers should contact Customer Service at 800-424-3278 to obtain a Returned Goods Authorization number to return their current product to and receive replacement product. Customers with questions were instructed to call Edwards Customer Service at 800-424-3278.
Quantity in commerce: S099: 171,587 units and S099B: 505,107 units
Distribution: Worldwide Distribution - USA (nationwide) and Canada.
Product codes and lots: Models S099 and S099B

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1749-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1749-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-17

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)