Z-0650-2013Class II

Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to...

Name: Z-0650-2013 Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to...
Creator: California Medical Laboratories Inc
Published: 2012-11-02
License: https://open.fda.gov/license/

California Medical Laboratories, Inc. / initiated 2012-11-02 / Terminated / root cause: manufacturing process

FDA source

California Medical Laboratories Inc began a recall of Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as... on 2012-11-02. FDA classified it as Class II and gives the reason as "California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the...". 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-0650-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-02
Posted: 2013-01-07
Terminated: 2013-03-04
Recalling firm: California Medical Laboratories, Inc.
Product: Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction Wands are indicated for use to remove excess fluid from the surgical field.
Product code: DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Reason for recall: California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: CalMed sent an Urgent Field Safety Notice dated November 2, 2012, to all affected customers by certified mail and additionally followed up via electronic mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact Sorin Group USA's Customers Service Department at +1-800-650-2623 to return any unused product and order replacements. Customers were also asked to communicate the important safety information to all potential users within their organization or any other organization where the affected product may have been transferred and to maintain awareness of this communication for an appropriate period of time to ensure effectiveness of the corrective action. Customers were asked to return all unused product to CalMed Labs. Customers with questions were instructed to contact California Medical Laboratories at +1-714-556-7365. For questions regarding this recall call 714-556-7365.
Quantity in commerce: S112468N=1000 units, S120196N=1400 units, & S120197N=1200 units
Distribution: Worldwide Distribution - USA including AZ, FL, CA, LA, CO, and MS. Internationally to Canada, Israel, Greece, Hong Kong, India, Ireland, Jordan, Lebanon, Malaysia, Netherlands, Russia, Saudi Arabia, South Africa and Spain.
Product codes and lots: Catalog No: SU-12202NS Lot No: S112468N, S120196N, S120197N

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0650-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0649-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-07
Z-0650-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-07

Product code DTS

K982891Class IICalifornia Medical Laboratories Inc. Standard and Small Rigid Tip Suction WandsCalifornia Medical Laboratories, Inc. / cleared 1998-09-30

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)