Recall Z-1584-2016— RESEARCH INSTRUMENTS LTD - SITE B
Class II · Terminated
Class II FDA medical device recall by RESEARCH INSTRUMENTS LTD - SITE B, initiated 2016-03-11, terminated 2021-03-02. It names one FDA 510(k) clearance: K003142. Product: 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: The units have been fitted with a potentially faulty power supply cable..
- Recalling firm
- RESEARCH INSTRUMENTS LTD - SITE B
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-11
- Terminated
- 2021-03-02
- Firm location
- Falmouth, N/A, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.