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Z-1584-2016 Class II Terminated

Recalled by RESEARCH INSTRUMENTS LTD - SITE B — Falmouth, N/A

FDA device recall Z-1584-2016 was initiated by RESEARCH INSTRUMENTS LTD - SITE B on March 11, 2016 and is designated Class II. Reason for recall: The units have been fitted with a potentially faulty power supply cable. The recall status is terminated (terminated March 2, 2021). Affected quantity: 380 units.

Recall Details

Product Type: Devices
Report Date: May 4, 2016
Initiation Date: March 11, 2016
Termination Date: March 2, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 380 units

Product Description

Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160 Product Usage: The Rl TDU500 Micromanipulator for Assisted Reproduction is used to accurately position microtools under a microscope for the techniques of Assisted Reproduction. The Rl Integra is a configuration comprising two TDU500 micromanipulators, two air syringes and temperature control system within a single housing.

Reason for Recall

The units have been fitted with a potentially faulty power supply cable.

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of: MA, NY and countries of : Algeria, Australia, Austria, Bahrain, Belgium, British Virgin Islands, Bulgaria, Canada, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Nigeria, Norway, Pakistan, Peru, Poland, Romania, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UAE, Ukraine, United Kingdom, and Vietnam,

Code Information

Serial numbers: 2-381