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 에 대한 현장 안전성 서한

Field Safety Notice

SN2002(03)

2002-06-13

Ireland

HPRA

http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/a-a-products&id=d19af825-9782-6eee-9b55-ff00008c97d0

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.

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.