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Class I Medical Device Recall: Multi-Med, Inc. Huber (Non-coring) Needles and Finished Devices Containing Huber Needles Labeled as "All-Med Medical Products, Inc." and "Marque...

Tue, 10/12/2010 - 9:34am
U.S. Food & Drug Administration

Huber needles are safety needles used on vascular access ports implanted in patients in need of repeated intravenous therapy. 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. These issues may potentially cause death.

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 to access ports implanted under the skin of patients. 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.

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:

  • 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.

Clinicians/Users:

  • Immediately discontinue use of the product.
  • If you must use the set, consider using an alternative, unaffected non-coring needle if possible. However if you do not have an alternate and unaffected non-coring needle, consider performing the following flushing procedures of the port as recommended by the FDA:
    • 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.

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:

Example of product labeling. Highlights are the catalog number (MW223Y-HT), product code (M1915H) and reorder number (55-1940).

    

SOURCE

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