Multi-Med, Inc. Huber (Non-coring) Needles and Finished Devices Containing Huber Needles Labeled as "All-Med Medical Products, Inc." and "Marquette Medical, Inc." Brands and Provided to Some Consignees in Bulk Without Labeling

Recall Class: Class I

Date Recall Initiated: August 30, 2010

Products:

Huber needles manufactured by Multi-Med, Inc and sold under the brand names “All-Med Medical Products, Inc.” and “Marquette Medical, Inc.” These products were also provided to consignees in bulk without labeling.

All 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.

To find the complete list of products affected by this recall, see the attachments below.

Samples of All-Med Medical Products, Inc. and Marquette Medical, Inc. product labeling highlighting identifying information are provided in Attachment C.

Use:

Huber needles are used on vascular access ports to access ports implanted under the skin of patients in need of repeated intravenous therapy. These needles are intended to penetrate the port septum without cutting or dislodging any silicone cores (or slivers) from the ports into which they are inserted.

Recalling Firm:

Multi-Med, Inc.
26 Victoria Ct.
Keene NH 03431

Reason for Recall:

Multi-Med has expanded its previous recall ucm224068 to include all Huber needles and finished products containing Huber needles distributed from July 12, 2005 to May 28, 2010.

A "coring" Huber needle could damage the implanted port by removing silicone slivers from the access membrane. The defect in the port as a result of coring can cause the ports to leak. The core can also potentially enter a patient’s body when the port is initially accessed if it is not flushed correctly. These issues may lead to the decreased effectiveness of the port, replacement of the port, infection, damage or death of tissue, swelling, or other serious adverse health consequences occurring as a result of the core travelling through blood vessels into the patient’s lungs or other organs. These issues may potentially cause death.

Public Contact:

Multi-Med Inc. representative Susan Starkey can be contacted by phone at 1-603-357-8733, Monday through Friday, from 8:00 to 5:00 PM (Eastern Standard Time) for instructions for disposition of the needles.

FDA District: New England

FDA Comments:
The company has advised distributors to:

• Immediately examine your inventory and quarantine product subject to the recall.
• Identify customers that have received these needles and notify them at once of this product recall.

FDA recommends clinicians and other users:

• Discontinue the use of the recalled product.
• If you do not have an alternate and unaffected non-coring needle, weigh the risk and benefits of continuing to use the affected product.
• Consider following FDA recommendations when using any Huber needle.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by FAX.

Useful Links:

• Information About Huber Needles
• MedWatch: The FDA Safety Information and Adverse Event Reporting Program

Attachment A: All-Med Medical Products, Inc. Huber Needles and Products Containing Huber Needles Affected by the Recall

Attachment B: Marquette Medical Products Containing Huber Needles Affected by the Recall

Attachment C: Samples of All-Med Medical Products, Inc. and Marquette Medical, Inc. Product Labeling