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

Posted Oct 11 2010 9:00pm

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:

PRODUCT CODEPRODUCT DESCRIPTIONREORDER NUMBERLOTS
M19119ga x 1" Winged Administration Set50-19317H007A
9F027A
M191H19ga x 1" RA Huber Needle55-19305J008A
9F039A
9F042A
M191Y19ga x 1" Winged Administration Set w/Y Site50-19326I048A
7G048A
8A005A
9F021A
M195H19ga x .5" RA Huber Needle55-19107D070A
M195Y19ga x .5" Winged Administration Set w/Y Site50-19128F064A
M1915H19ga x 1.5" RA Huber Needle55-19406E055A
M1915Y19ga x 1.5" Winged Administration Set w/Y Site50-19425G011A
5H018A
M197519ga x .75" Winged Administration Set50-19217EO31A
7G045A
8L040A
9E013A
9F025A
.
M1975H19ga x .75" RA Huber55-19205I062A
8L038A
M1975S19ga x .75" Standard Bore Winged Administration Set50-19237G055A
9H008A
M1975Y19ga x .75" Winged Administration Set w/Y Site50-19229B026M
M20120ga x 1" Winged Administration Set50-20315G059A
5H042A
5K013A
5K022A
6K034A
7A002A
7I036A
7J007A
9F036A
9F044A
M201H20ga x 1" RA Huber Needle55-20305H050A
6H037A
7A041A
7I012A
7J031A
9J014A
9K014A
M201HS20ga x 1" Straight Huber Needle55-20357D049A
8C053A
8K017A
M201S20ga x 1" Standard Bore Winged Administration Set50-20336K031A
M201Y20ga x 1" Winged Administration Set w/Y Site50-20325G055A
5J034A
5J036A
6H027A
6I010A
6J053A
6K027A
7J008A
8D025A
8F029A
8L043A
9A024A
M201520ga x 1.5" Winged Administration Set50-20417F048A
8B011A
8G006A
9C031A
9D020A
M2015H20ga x 1.5" 90°RA Huber Needle55-20405H058A
5J007A
6H041A
7J029A
8D029A
8K055A
8K058A
8L034A
M2015HS20ga x 1.5" Straight Huber Needle55-20456A061A
6E030A
6E056A
6J014A
6K035A
7D006A
7E047A
7H022A
8J030A
8K005A
9B014A
9B044A
9H003A
M2015Y20ga x 1.5" Winged Administration Set w/Y Site50-20425G007A
6I038A
7F049A
7H014A
9F024A
M20520ga x .5" Winged Administration Set50-20116A001A
9G036A
M205H20ga x .5" 90°RA Huber Needle55-20106J022A
7D069A
M205Y20ga x .5" Winged Administration Set w/Y Site50-20126A028A
7E044A
9G039A
M207520ga x .75" Winged Administration Set50-20215J012A
6A003A
6B056A
6E004A
6E011A
6H052A
6K026A
6L005A
7A016A
7B060A
7C027A
7D001A
7F008A
7I010A
7L026A
8J065A
9E024A
9F020A
9G033A
9H018A
M2075H20ga x .75" 90°RA Huber Needle55-20205H053A
7I014A
8B027A
M2075S20ga x .75" Standard Bore Winged Administration Set50-20237F024A
M2075Y20ga x .75" Winged Administration Set w/Y Site50-20220D013A
5J017A
6B060A
6D040A
6L052A
7B059A
7C025A
7C034A
7E076A
7K011A
8C051A
8F028A
8F063A
8H016A
8J019A
9D022A
9D034A
9E018A
9K026A
M22122ga x 1" Winged Administration Set50-22315I030A
7F036A
7F046A
7G023A
8K011A
9K024A
M221H22ga x 1" RA Huber Needle55-22305K044A
7D052A
9A009A
9L019A
M221HS-NS22ga x 1" Straight Huber Needle - Bulk55-22305J031M
6B042A
6C016M
6K008A
6L040A
7C061M
M221S22ga x 1" Standard Bore Winged Administration Set50-22337I005A
M221Y22ga x 1" Winged Administration Set w/Y Site50-22326G023A
6H014A
6J046A
7A001A
8K013A
9I010A
M221520ga x 1.5" Winged Administration Set50-22416A030A
6F031A
6H050A
6L044A
7A040A
7D048A
7G012A
7J055A
7K035A
7L019A
7L024A
8H044A
8I014A
8I044A
8L022A
8L033A
9B034A
9C034A
9D021A
9F037A
9F049A
9J032A
9K029A
M2215H22ga x 1.5" 90 °RA Huber Needle55-22405K045A
7D058A
7K038A
9E046A
 M2215HS22ga x 1” Straight Huberer Needle55-22357D017A
9K021A
M2215HS22ga x 1.5" Straight Huber Needle55-22450C006A
6D013A
6I017A
6J015A
6K037A
7E054A
7F042A
8A069A
8I061A
9C035A
9G030A
9I026A
9I027A
9J039A
9K020A
M2215S22ga x 1.5" Standard Bore Winged Administration Set50-22437D061A
7G037A
M2215Y22ga x 1.5" Winged Administration Set w/Y Site50-22427B020A
8I045A
9K022A
M22522ga x .5" Winged Administration Set50-22116E057A
7C013A
7G024A
8D013A
8K025A
9F051A
M225H22ga x .5” RA Huber Needle55-22106J025A
7B013A
7C024A
M225Y22ga x .5” Winged Administration Set w/Y Site50-22128F024A
M227522ga x .75" Winged Administration Set50-22215I024A
6G037A
6H010A
6J006A
6L056A
7A018A
7A022A
7H012A
7J050A
8B016A
8K035A
9K031A
9K040A
M2275H22ga x .75” 90°RA Huber Needle55-22205H057A
7B031A
8L006A
8L036A
M2275HS22ga x .75" Straight Huber Needle55-22256J021A
7D050A
7H038A
M2275HS-NS22ga x .75" Straight Huber Needle-Bulk55-22355I038A
6B014M
M2275S22ga x .75" Standard Bore Winged Administration Set50-22238F002A
M2275Y22ga x .75" Winged Administration Set w/Y Site50-22225G001A
6H009M
7D064A
7H015A
7L014A
8L021A
9G056A
9J051A
CATALOG NUMBERPRODUCT DESCRIPTIONLOT NUMBERS
MW191Trap-A Safety Huber Needle 19ga x 1" Winged Administration Set6A051M
6C059M
7J002M
MW191-HTTrap-A Safety Huber Needle 19ga x 1" Winged Administration Set5G040M
5H030M
9E026M
MW191YTrap-A Safety Huber Needle 19ga x 1" Winged Administration Set w/Y Site5G009M
5K015M
5K032M
6K029M
6K049M
8B008M
MW191Y-HTTrap-A Safety Huber Needle 19ga x 1" Huber Trap with Needleless Y5F060M
5H059M
MW193Trap-A Safety Huber Needle 19ga x .75" Winged Administration Set5H027M
MW193-HTTrap-A Safety Huber Needle 19ga x .75" Winged Administration Set5G003M
5K031M
MW193YTrap-A Safety Huber Needle 19ga x .75" Winged Administration Set w/Y Site5H028M
5I051M
6K050M
7G033M
7G047M
7H023M
MW201Trap-A Safety Huber Needle 20ga x 1" Winged Administration Set5K033M
6A059M
6G007M
6I040M
MW201YTrap-A Safety Huber Needle 20ga x 1" Winged Administration Set w/Y Site5I054M
6A039M
6E023M
7H024M
8F031M
9C032M
MW201Y-HTTrap-A Safety Huber Needle 20ga x 1" Huber Trap with Needleless Y5G014M
5I002M
5I067M
7G026M
7H051M
8L032M
MW203Trap-A Safety Huber Needle 20ga x .75" Winged Administration Set5I032M
5K034M
6B044M
6C035
6C048M
6C065M
6H004M
7B022M
MW203-HTTrap-A Safety Huber Needle 20ga x .75" Huber Trap5G010M
5H034M
5H037M
7D054M
8A033M
8K061M
9C013M
9C029M
MW203YTrap-A Safety Huber Needle 20ga x .75" Winged Administration Set w/Y Site5I049M
6B050M
6J040M
7D023M
7H063M
MW203Y-HTTrap-A Safety Huber Needle 20ga x .75" Huber Trap with Needleless Y5H041M
5H071M
7E065M
8C072M
8H042M
8I046M
9A033M
9E028M
MW221Trap-A Safety Huber Needle 22ga x 1" Winged Administration Set6E001M
6J013M
MW221YTrap-A Safety Huber Needle 22ga x 1 Winged Administration Set w/Y Site5I059M
5I060M
5K057M
6A002M
MW223Trap-A Safety Huber Needle 22ga x .75" Winged Administration Set5H036M
5J020M
6E029M
6H003M
6K028M
7C032M
MW223-HTTrap-A Safety Huber Needle 22ga x .75" Huber Trap5H049M
5I007M
5I061M
8J034M
9E034M
MW223YTrap-A Safety Huber Needle 22ga x .75" Winged Administration Set w/Y Site5G033M
5H007M
5I050M
6F029M
7J003M
MW223Y-HTTrap-A Safety Huber Needle 22ga x .75" Huber Trap with Needleless Y5F069M
5H088M
5K041M
MWS191Trap-A Safety Huber Needle 19ga x 1" Standard Bore Winged Administration Set6B070M
6D030M
8D040M
9I012M
MWS193Trap-A Safety Huber Needle 19ga x .75" Standard Bore Winged Administration Set5G022M
6B021M 6E039M
7C030M
MWS201Trap-A Safety Huber Needle 20ga x 1" Standard Bore Winged Administration Set0D003M
5l060M
6A060M
6B052M
6E028M
6H056M
6I039M
7B016M
7D008M
7E056M
7F038M
7F039M
7G052M
7K053M
8F055M
9E048M
MWS203Trap-A Safety Huber Needle 20ga x .75" Winged Administration Set w/Y Site0B053M
0C050M 5G020M
5G039M
5I031M
6A052M
6B029M
6F048M
6J012M
6L014M
7B021M
7C068M
7H062M
7K051M
7L022M
8B053M
8G009M
8L019M
9A012M
9C033M
9K048M
MWS221Trap-A Safety Huber Needle 22ga x 1" Standard Bore Winged Administration Set5H038M
6B036M
6D031M
MWS223Trap-A Safety Huber Needle 22ga x .75" Standard Bore Winged Administration Set5L041M
6A062M
6F011M
6F013M
6K060M
8K054M

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

    
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