Events

Field Safety Notices about curettes (flexible and rigid), uterine dilators (e.g. Laminaria), endometrial sampling sets, fetal blood samplers, fetal bladder drains, laparoscopy accessories, bone marrow needles, aspiration sets, biopsy pipettes, and harvesting pumps used in in-vitro fertilization

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by A & A Medical.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here

Type of Event
Field Safety Notice
Event Number
SN2002(03)
Date
2002-06-13
Event Country
Ireland
Event Source
HPRA
Event Source URL
http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/a-a-products&id=d19af825-9782-6eee-9b55-ff00008c97d0
Notes / Alerts

"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
Extra notes in the data
Reason
Fda is alerting consumers and health care professionals of a nationwide/international recall of all medical devices labelled as sterile or ethylene oxide processed, manufactured by a&a of alpharetta, georgia. the firm also does business as a&a medical/rocket usa, and lifequest. some of the products manufactured by this company have been labelled and shipped as sterile but in fact may not have undergone any sterilization process. this has the potential of causing death or serious injury such as infection, infertility, and miscarriage. as a result, the company is recalling all products labelled as sterile and shipped nationwide and internationally to canada, egypt, italy and lebanon.
Action
Do not use any A & A Medical, Inc., Rocket USA, or Lifequest products. Please ensure that those responsible for the purchase of these devices are made aware of this issue.

Device

curettes (flexible and rigid), uterine dilators (e.g. Laminaria), endometrial sampling sets, feta...

Model / Serial
Product Description
A&A; Products
Manufacturer
A & A Medical

Manufacturer

A & A Medical

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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