Z-1985-2013Class II

Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs

Name: Z-1985-2013 Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs
Creator: Sorin Group USA, Inc.
Published: 2013-07-08
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2013-07-08 / Terminated / root cause: manufacturing process

FDA source

Sorin Group USA, Inc. began a recall of Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs on 2013-07-08. FDA classified it as Class II and gives the reason as "Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch". 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-1985-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-08
Posted: 2013-08-20
Terminated: 2014-01-28
Recalling firm: LivaNova USA, Inc.
Product: Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: On 7/8/13, customers and distributors were sent a "Field Safety Notice Product Recall" letter and requested to return unused Edwards Suction Wands found in the Perfusion Packs to the Sorin Group. Customers are to contact Sorin Group Customer Service at 1-800-650-6502 to receive instructions for returning the affected Edwards Suction Wand to Sorin. Customers were also advised to not discard affected product.
Quantity in commerce: 18,927 packs
Distribution: Nationwide Distribution
Product codes and lots: Model S099B

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1985-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1985-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-20

Product code DWF

K881330Class IICobe Heart/lung Perfusion and Cardioplegia PackCobe Laboratories, Inc. / cleared 1988-06-10

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)