Original Date Issued: January 26, 2010
Date updated: October 25, 2010
Audience: Healthcare Practitioners and Patients/Caregivers
Medical Specialties: Multiple, including Interventional Radiologists, Oncologists, Infusion Nurses Device
- Recalls UPDATED October 25, 2010
- All-Med Medical Products, Inc. and Marquette Medical, Inc. Huber Needles and Administration Sets Containing Huber needles Distributed from July 12, 2005 to May 28, 2010 (Recall initiated August 30, 2010)
- Navilyst Medical Inc. Vaxel Implantable Port Systems Containing Huber Needles manufactured from May 2, 2007 to May 1, 2010 (Recall initiated May 26, 2010)
- Exel Huber Needles, Exel Huber Infusion Sets and Exel “Securetouch+†Safety Huber Infusion Sets manufactured between February 22, 2007 and September 17, 2010 (Recall initiated December 23, 2009)
- Letter to Manufacturers
Back to Top]
Back to Top]
FDA Activities
Recalls UPDATED October 25, 2010
All-Med Medical Products, Inc. and Marquette Medical, Inc. Huber Needles and Administration Sets Containing Huber needles Distributed from July 12, 2005 to May 28, 2010 (Recall initiated August 30, 2010)
FDA Activities
Recalls UPDATED October 25, 2010
All-Med Medical Products, Inc. and Marquette Medical, Inc. Huber Needles and Administration Sets Containing Huber needles Distributed from July 12, 2005 to May 28, 2010 (Recall initiated August 30, 2010)
On October 12, 2010 the FDA announced a Class I recall ofHuber needles manufactured by Multi-Med, Inc and sold under the brand names “All-Med Medical Products, Inc.†and “Marquette Medical, Inc.†All-Med and Marquette Huber needles and products containing Huber needles, such as administration sets, distributed from July 12, 2005 to May 28, 2010 are affected by the recall.
This is an expansion of Multi-Med’s August 26, 2010 recall. The recall now includes all Multi-Med Huber needles and finished products containing Huber needles distributed from July 12, 2005 to May 28, 2010.
See the recall notice for a complete list of the affected products.
Facilities that have products affected by the recall should immediately discontinue the use of the needles and contact Multi-Med Inc. FDA recommends that users take the precautions listed in the Recommendations section below when using any Huber needle.
Direct questions concerning this recall to:
Susan Starkey
1-603-357-8733
Monday through Friday
8:00 AM to 5:00 PM (Eastern Standard Time)
[Back to Top]
recall notice for a complete listing of the affected products.
Facilities that have products affected by the recall should immediately discontinue the use of the needles and return unused product to Navilyst Medical, Inc. FDA recommends that users take the precautions listed in the Recommendations section below when using any Huber needle.
Direct all questions concerning this recall to:
Navilyst Medical, Inc.
800-833-9973
FAX 518-742-4450
8:30 AM and 7:00 PM (Eastern Standard Time)
[Back to Top]
recall notice for a complete listing of the affected products.
Hospitals, clinics and patients who have needles from these lists should immediately stop using these affected products and return any unused products to Exelint International Corporation. FDA recommends that users take the precautions listed in the Recommendations section below when using any Huber needle.
Direct all questions concerning this recall to:
Attn: Armand Hamid
EXEL International
5408 West Centinela Ave
Los Angeles, Calif. 90045-1504
Tel. 800-940-3935
Fax 800-308-5048
E-mail: [email protected]
Letter to Manufacturers
In 2009, the FDA issued a letter to manufacturers of other Huber needles to address design and manufacturing concerns. The FDA continues to work closely with all manufacturers of Huber needles to understand the potential causes for coring and identify corrective measures
[Back to Top]
Recommendations
While a more thorough investigation of this situation continues, FDA continues to recommend that health care professionals consider taking the following precautions: ÂÂ
- Avoid flushing the syringe when initially confirming needle patency upon accessing the port. If the needle has cored the port, flushing may introduce the core into the patient’s body, and could lead to serious adverse events.
- When possible, upon accessing the port, consider aspirating a small amount of blood from the port after septum puncture, then discard the syringe with its contents. This step may recapture the silicone sliver. If the needle becomes clogged when attempting to aspirate, remove the needle, discard it and select a new one.
- Watch for signs and/or symptoms that may indicate damage to the port’s septum, such as medication leakage resulting in inadequate therapy delivery, along with tissue, nerve and/or muscle damage; and redness of the surrounding area.
- Patients should continue to follow their doctor’s recommendations for receiving treatment.
[Back to Top]
file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Healthcare personnel employed by facilities that are subject to FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.
Device manufacturers must comply with the Medical Device Report (MDR) regulations
To help us learn as much as possible about the adverse events associated with Huber needles, please include the following information in your reports, if available:
- Patient information (age, indication for use, existing medical conditions)
- Details of the adverse event
- Therapy being infused
- Port information (type, manufacturer, anatomical location)
- Type of Huber needle used (manufacturer, lot/serial numbers)
- Unexpected health issues (such as stroke or MI)
[Back to Top]
[email protected] or 800-638-2041.
[Back to Top]
http://www.fda.gov/MedicalDevices/ Safety/AlertsandNotices/ucm198719.htm
[Back to Top]
This document reflects FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices. The nature, magnitude and possible public health impact of this situation are not yet clear.
   ÂÂ