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

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:

• Information About Huber Needles ucm198719
• MedWatch: The FDA Safety Information and Adverse Event Reporting Program

PRODUCT CODE	PRODUCT DESCRIPTION	REORDER NUMBER	LOTS
M191	19ga x 1" Winged Administration Set	50-1931	7H007A 9F027A
M191H	19ga x 1" RA Huber Needle	55-1930	5J008A 9F039A 9F042A
M191Y	19ga x 1" Winged Administration Set w/Y Site	50-1932	6I048A 7G048A 8A005A 9F021A
M195H	19ga x .5" RA Huber Needle	55-1910	7D070A
M195Y	19ga x .5" Winged Administration Set w/Y Site	50-1912	8F064A
M1915H	19ga x 1.5" RA Huber Needle	55-1940	6E055A
M1915Y	19ga x 1.5" Winged Administration Set w/Y Site	50-1942	5G011A 5H018A
M1975	19ga x .75" Winged Administration Set	50-1921	7EO31A 7G045A 8L040A 9E013A 9F025A .
M1975H	19ga x .75" RA Huber	55-1920	5I062A 8L038A
M1975S	19ga x .75" Standard Bore Winged Administration Set	50-1923	7G055A 9H008A
M1975Y	19ga x .75" Winged Administration Set w/Y Site	50-1922	9B026M
M201	20ga x 1" Winged Administration Set	50-2031	5G059A 5H042A 5K013A 5K022A 6K034A 7A002A 7I036A 7J007A 9F036A 9F044A
M201H	20ga x 1" RA Huber Needle	55-2030	5H050A 6H037A 7A041A 7I012A 7J031A 9J014A 9K014A
M201HS	20ga x 1" Straight Huber Needle	55-2035	7D049A 8C053A 8K017A
M201S	20ga x 1" Standard Bore Winged Administration Set	50-2033	6K031A
M201Y	20ga x 1" Winged Administration Set w/Y Site	50-2032	5G055A 5J034A 5J036A 6H027A 6I010A 6J053A 6K027A 7J008A 8D025A 8F029A 8L043A 9A024A
M2015	20ga x 1.5" Winged Administration Set	50-2041	7F048A 8B011A 8G006A 9C031A 9D020A
M2015H	20ga x 1.5" 90°RA Huber Needle	55-2040	5H058A 5J007A 6H041A 7J029A 8D029A 8K055A 8K058A 8L034A
M2015HS	20ga x 1.5" Straight Huber Needle	55-2045	6A061A 6E030A 6E056A 6J014A 6K035A 7D006A 7E047A 7H022A 8J030A 8K005A 9B014A 9B044A 9H003A
M2015Y	20ga x 1.5" Winged Administration Set w/Y Site	50-2042	5G007A 6I038A 7F049A 7H014A 9F024A
M205	20ga x .5" Winged Administration Set	50-2011	6A001A 9G036A
M205H	20ga x .5" 90°RA Huber Needle	55-2010	6J022A 7D069A
M205Y	20ga x .5" Winged Administration Set w/Y Site	50-2012	6A028A 7E044A 9G039A
M2075	20ga x .75" Winged Administration Set	50-2021	5J012A 6A003A 6B056A 6E004A 6E011A 6H052A 6K026A 6L005A 7A016A 7B060A 7C027A 7D001A 7F008A 7I010A 7L026A 8J065A 9E024A 9F020A 9G033A 9H018A
M2075H	20ga x .75" 90°RA Huber Needle	55-2020	5H053A 7I014A 8B027A
M2075S	20ga x .75" Standard Bore Winged Administration Set	50-2023	7F024A
M2075Y	20ga x .75" Winged Administration Set w/Y Site	50-2022	0D013A 5J017A 6B060A 6D040A 6L052A 7B059A 7C025A 7C034A 7E076A 7K011A 8C051A 8F028A 8F063A 8H016A 8J019A 9D022A 9D034A 9E018A 9K026A
M221	22ga x 1" Winged Administration Set	50-2231	5I030A 7F036A 7F046A 7G023A 8K011A 9K024A
M221H	22ga x 1" RA Huber Needle	55-2230	5K044A 7D052A 9A009A 9L019A
M221HS-NS	22ga x 1" Straight Huber Needle - Bulk	55-2230	5J031M 6B042A 6C016M 6K008A 6L040A 7C061M
M221S	22ga x 1" Standard Bore Winged Administration Set	50-2233	7I005A
M221Y	22ga x 1" Winged Administration Set w/Y Site	50-2232	6G023A 6H014A 6J046A 7A001A 8K013A 9I010A
M2215	20ga x 1.5" Winged Administration Set	50-2241	6A030A 6F031A 6H050A 6L044A 7A040A 7D048A 7G012A 7J055A 7K035A 7L019A 7L024A 8H044A 8I014A 8I044A 8L022A 8L033A 9B034A 9C034A 9D021A 9F037A 9F049A 9J032A 9K029A
M2215H	22ga x 1.5" 90 °RA Huber Needle	55-2240	5K045A 7D058A 7K038A 9E046A
M2215HS	22ga x 1” Straight Huberer Needle	55-2235	7D017A 9K021A
M2215HS	22ga x 1.5" Straight Huber Needle	55-2245	0C006A 6D013A 6I017A 6J015A 6K037A 7E054A 7F042A 8A069A 8I061A 9C035A 9G030A 9I026A 9I027A 9J039A 9K020A
M2215S	22ga x 1.5" Standard Bore Winged Administration Set	50-2243	7D061A 7G037A
M2215Y	22ga x 1.5" Winged Administration Set w/Y Site	50-2242	7B020A 8I045A 9K022A
M225	22ga x .5" Winged Administration Set	50-2211	6E057A 7C013A 7G024A 8D013A 8K025A 9F051A
M225H	22ga x .5” RA Huber Needle	55-2210	6J025A 7B013A 7C024A
M225Y	22ga x .5” Winged Administration Set w/Y Site	50-2212	8F024A
M2275	22ga x .75" Winged Administration Set	50-2221	5I024A 6G037A 6H010A 6J006A 6L056A 7A018A 7A022A 7H012A 7J050A 8B016A 8K035A 9K031A 9K040A
M2275H	22ga x .75” 90°RA Huber Needle	55-2220	5H057A 7B031A 8L006A 8L036A
M2275HS	22ga x .75" Straight Huber Needle	55-2225	6J021A 7D050A 7H038A
M2275HS-NS	22ga x .75" Straight Huber Needle-Bulk	55-2235	5I038A 6B014M
M2275S	22ga x .75" Standard Bore Winged Administration Set	50-2223	8F002A
M2275Y	22ga x .75" Winged Administration Set w/Y Site	50-2222	5G001A 6H009M 7D064A 7H015A 7L014A 8L021A 9G056A 9J051A

CATALOG NUMBER	PRODUCT DESCRIPTION	LOT NUMBERS
MW191	Trap-A Safety Huber Needle 19ga x 1" Winged Administration Set	6A051M 6C059M 7J002M
MW191-HT	Trap-A Safety Huber Needle 19ga x 1" Winged Administration Set	5G040M 5H030M 9E026M
MW191Y	Trap-A Safety Huber Needle 19ga x 1" Winged Administration Set w/Y Site	5G009M 5K015M 5K032M 6K029M 6K049M 8B008M
MW191Y-HT	Trap-A Safety Huber Needle 19ga x 1" Huber Trap with Needleless Y	5F060M 5H059M
MW193	Trap-A Safety Huber Needle 19ga x .75" Winged Administration Set	5H027M
MW193-HT	Trap-A Safety Huber Needle 19ga x .75" Winged Administration Set	5G003M 5K031M
MW193Y	Trap-A Safety Huber Needle 19ga x .75" Winged Administration Set w/Y Site	5H028M 5I051M 6K050M 7G033M 7G047M 7H023M
MW201	Trap-A Safety Huber Needle 20ga x 1" Winged Administration Set	5K033M 6A059M 6G007M 6I040M
MW201Y	Trap-A Safety Huber Needle 20ga x 1" Winged Administration Set w/Y Site	5I054M 6A039M 6E023M 7H024M 8F031M 9C032M
MW201Y-HT	Trap-A Safety Huber Needle 20ga x 1" Huber Trap with Needleless Y	5G014M 5I002M 5I067M 7G026M 7H051M 8L032M
MW203	Trap-A Safety Huber Needle 20ga x .75" Winged Administration Set	5I032M 5K034M 6B044M 6C035 6C048M 6C065M 6H004M 7B022M
MW203-HT	Trap-A Safety Huber Needle 20ga x .75" Huber Trap	5G010M 5H034M 5H037M 7D054M 8A033M 8K061M 9C013M 9C029M
MW203Y	Trap-A Safety Huber Needle 20ga x .75" Winged Administration Set w/Y Site	5I049M 6B050M 6J040M 7D023M 7H063M
MW203Y-HT	Trap-A Safety Huber Needle 20ga x .75" Huber Trap with Needleless Y	5H041M 5H071M 7E065M 8C072M 8H042M 8I046M 9A033M 9E028M
MW221	Trap-A Safety Huber Needle 22ga x 1" Winged Administration Set	6E001M 6J013M
MW221Y	Trap-A Safety Huber Needle 22ga x 1 Winged Administration Set w/Y Site	5I059M 5I060M 5K057M 6A002M
MW223	Trap-A Safety Huber Needle 22ga x .75" Winged Administration Set	5H036M 5J020M 6E029M 6H003M 6K028M 7C032M
MW223-HT	Trap-A Safety Huber Needle 22ga x .75" Huber Trap	5H049M 5I007M 5I061M 8J034M 9E034M
MW223Y	Trap-A Safety Huber Needle 22ga x .75" Winged Administration Set w/Y Site	5G033M 5H007M 5I050M 6F029M 7J003M
MW223Y-HT	Trap-A Safety Huber Needle 22ga x .75" Huber Trap with Needleless Y	5F069M 5H088M 5K041M
MWS191	Trap-A Safety Huber Needle 19ga x 1" Standard Bore Winged Administration Set	6B070M 6D030M 8D040M 9I012M
MWS193	Trap-A Safety Huber Needle 19ga x .75" Standard Bore Winged Administration Set	5G022M 6B021M 6E039M 7C030M
MWS201	Trap-A Safety Huber Needle 20ga x 1" Standard Bore Winged Administration Set	0D003M 5l060M 6A060M 6B052M 6E028M 6H056M 6I039M 7B016M 7D008M 7E056M 7F038M 7F039M 7G052M 7K053M 8F055M 9E048M
MWS203	Trap-A Safety Huber Needle 20ga x .75" Winged Administration Set w/Y Site	0B053M 0C050M 5G020M 5G039M 5I031M 6A052M 6B029M 6F048M 6J012M 6L014M 7B021M 7C068M 7H062M 7K051M 7L022M 8B053M 8G009M 8L019M 9A012M 9C033M 9K048M
MWS221	Trap-A Safety Huber Needle 22ga x 1" Standard Bore Winged Administration Set	5H038M 6B036M 6D031M
MWS223	Trap-A Safety Huber Needle 22ga x .75" Standard Bore Winged Administration Set	5L041M 6A062M 6F011M 6F013M 6K060M 8K054M