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A&A Products
Notice type:
Recall
Date:
13/06/2002
Product name or type:
A&A Products
Reference:
SN2002(03)
Manufacturer Or Supplier:
A & A Medical of Aipharetta or A& A Medical / Rocket USA or Lifequest
Note:
The
A&A MEDICAL/ROCKET USA/LIFEQUEST
products that are referred to in this safety notice do not relate to the
ROCKET MEDICAL
products that are distributed by Fannin Healthcare.
Target Audience:
Hospital Administrators; Risk Managers; Director, Central Supply; Director, Department of Obstetrics and Gynaecology; Director, Department of Surgery; Ambulatory Surgical Centres
Problem Or Issue:
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
Background Information Or Related Documents:
This firm manufactures many types of OB/GYN and surgical devices. These devices are used only in the clinical setting during surgical and gynaecological procedures. The recall includes, but is not limited to 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.
List of Known Ob/Gyn and Surgical Devices Recalled by A & A Medical, Inc. (This is a partial list; as known at the time of this alert.)
Curette (flexible and rigid, all sizes)
Collection set tubing
Aspiration sets
Laminaria
IUD removal instruments
Mucus samplers
Biopsy pipettes/Endometrial sampling sets
Uterine sounds
Pratt dilator set
Ovum forceps
Tenaculum forceps
Needle extenders and guide
Fetal bladder drain
Fetal blood sampler
Harvesting Pump and accessories
Loop/ball electrodes
Laparoscopy accessories
A& A Products Document
Actions To Be Taken:
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.
Further Information:
All adverse incidents relating to a medical device should be reported to the:
Medical Devices Department
Health Products Regulatory Authority
Earlsfort Centre
Earlsfort Terrace
Dublin 2
If you have any enquiries, you may contact the Medical Devices Department at:
Telephone: +353-1-6764971
Fax: +353-1-6767836
Email:
vigilance@imb.ie
Website:
www.hpra.ie
SN2002(03): A&A Products
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Date Printed: 19/04/2024