International Medical Devices Database

Manufacturer Address
California Medical Laboratories Inc, 1570 Sunland Ln, Costa Mesa CA 92626-1515
Source
USFDA
5 Events

5 devices in the database

Device Recall Malleable Pericardial Sump

Model / Serial
Catalog Number SU-20802, Lot Numbers: S040870 S041515 S050537 S050907 S050919 S051982 S052118 S052325 S060056 S060158 S060909 S060924 S070307 S071047 S071462NS S071463 S071620 S071754 and S071985.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA, Turkey, Brazil, Germany, Italy, Spain, Philippines, South Africa, Japan, Israel, Saudi Arabia, United Arab Emirates, India, Ireland, China, Hungary, Poland, Taiwan, Belgium, Pakistan, Lithuania, Greece, Canada, Syria, Israel, Austria, Denmark, Bangladesh, Costa Rica, Mexico, Spain, and Sultanate of Oman.
Product Description
CalMed Malleable Pericardial Sump, Single Use Only. Do Not Reuse. REF SU-20802; CalMed Laboratories, Costa Mesa, CA 92626

Device Recall Pericardial Sump

Model / Serial
Catalog Number SU-20602, Lot Numbers: S040846 S040754 S040914 S041006 S041122 S050061NS S050232 S050233 S050329 S050335NS S050416NS S050538NS S050741 S050759NS S050766NS S050858 S050923NS S050943NS S051041 S051130 S051151 S051175 S051275NS S051318NS S051356NS S051402NS S051490 S051511 S051560NS S051582NS S051596NS S051677ES S051844NS S051881 S051906ES S051925 S052007NS S052142NS S052193NS S052295 S052338NS S060045 S060092NS S060202 S060285 S060401NS S060402NS S060454NS Lot No. S060492NS S060683NS S060965NS S061010NS S061226 S061434 S061441NS S061513NS S061695NS S061760NS S061838NS S061916 S062015NS S062055NS S062132 S070135NS S070252NS S070324 S070482NS S070501NS S070633 S070820NS S070870NS S070882 S070998 S071002NS S071456NS S071457NS S071458 S071459NS S071460NS S071534 S071606 S071607 S071688 S071731NS S071766 S071989 S072100NS S072121NS, and S072133NS
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA, Turkey, Brazil, Germany, Italy, Spain, Philippines, South Africa, Japan, Israel, Saudi Arabia, United Arab Emirates, India, Ireland, China, Hungary, Poland, Taiwan, Belgium, Pakistan, Lithuania, Greece, Canada, Syria, Israel, Austria, Denmark, Bangladesh, Costa Rica, Mexico, Spain, and Sultanate of Oman.
Product Description
CalMed Pericardial Sump, with 1/4"/0.635 cm Connector, Single Use Only. Do Not Reuse; REF SU-20602; CalMed Laboratories, Costa Mesa, CA 92626

Device Recall Pericardial Sump

Model / Serial
Catalog Number SU-20601, Lot Number S03482
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA, Turkey, Brazil, Germany, Italy, Spain, Philippines, South Africa, Japan, Israel, Saudi Arabia, United Arab Emirates, India, Ireland, China, Hungary, Poland, Taiwan, Belgium, Pakistan, Lithuania, Greece, Canada, Syria, Israel, Austria, Denmark, Bangladesh, Costa Rica, Mexico, Spain, and Sultanate of Oman.
Product Description
CalMed Pericardial Sump, with 1/8"/0.3175 cm Connector Single Use Only. Do Not Reuse. REF SU-20601; CalMed Laboratories, Costa Mesa, CA 92626

Device Recall CalMed SU12202NS

Model / Serial
Catalog No: SU-12202NS Lot No: S112468N, S120196N, S120197N
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
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 Description
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.

Device Recall CalMed SU12202

Model / Serial
Catalog No: SU-12202 Lot No: S112462, S111480
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
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 Description
Sterile Rigid Tip Suction Wand || The Suction Wands are indicated for use to remove excess fluid from the surgical field.

One manufacturer with a similar name

Learn more about the data here

California Medical Laboratories Inc.

Manufacturer Parent Company (2017)
LivaNova PLC
Source
HPRA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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