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Class I Medical Device Recall: Multi-Med, Inc., 22 Gauge x 1 inch Straight and Right Angle Huber Needles and Navilyst Medical In

Posted Aug 25 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: May 26, 2010

Products:

Multi-Med, Inc.

  • 22 Gauge x 1 inch straight Huber needles
    Model 10600218, Lot 9B020M.
  • 22 Gauge Right Angle x 1 inch Huber needles
    Model 10600219, Lot 9B017M

These products were not sold individually; they were sold to Navilyst and packaged in certain lots of Vaxcel Implantable Vascular Access Systems. The Navilyst vascular access systems containing these defective needles can be identified in the list below.

Navilyst Medical, Inc.*

  • Certain lots of Vaxcel Implantable Vascular Access Systems with PASV (Pressure Activated Safety Valve) Technology
  • Certain lots of Vaxcel Implantable Vascular Access Systems

* Navilyst Medical Inc. bought Boston Scientific Oncology Division in 2008; therefore, some recalled Vaxcel Implantable Vascular Access Systems are labeled as Boston Scientific products.

To find the complete list of products affected by this recall, see list below (Navilyst Medical, Inc. and Boston Scientific Vaxcel Implantable Vascular Access Systems Containing Huber Needles: Products Affected by the Class I Huber Needle Recall).

The affected devices were manufactured from May 2, 2007 to May 1, 2010 and were distributed from May 2, 2007 to May 1, 2010.

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 Firms:

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

Navilyst Medical, Inc.
10 Glens Falls Technical Park
Glens Falls, New York 12801

Reason for Recall:

In September and November 2009, FDA sampled and tested Navilyst Medical, Inc. products containing Huber-style needles manufactured by Multi-Med, Inc. FDA testing determined that these needles “cored” in 23 to 86 percent of tests.

Public Contact:
Navilyst Medical Inc. may be contacted by phone at 1-800-833-9973, Monday through Friday, during the hours of 8:00 AM and 7:00 PM (Eastern Standard Time); and by FAX at 1-518-742-4450.
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 Districts: New York (Navilyst Medical, Inc.) and New England (Multi-Med, Inc.)

FDA Comments:
The company has advised:

Distributors:

  • Immediately examine your inventory and quarantine product subject to therecall.
  • 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 kit, 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:


List of Affected Products: Navilyst Medical, Inc. Vaxcel Implantable Vascular Access Systems Containing Huber Needles: Products Affected by the Class I Huber Needle Recall. This list also includes those products labeled under Boston Scientific.

NAVILYST MEDICAL INC. PRODUCTS

ProductCatalog NumberUPN NumberLot Number
Vaxcel Port with PASV Titanium Mini-Port with PASV Valve and 6F Polyurethane Catheter (1.1 mm/1.9 mm)
Navilyst Medical Logo. Follow link for full printed address.
45-213M001452130
119232712525841303564
119422812581011307354
119810312590571307625
119971712637101308513
120069912668091313095
120353312676891316267
121435212713091343197
121464812736981346939
121565612765971354063
121902212803291360019
122562712851431364758
122841112868321365528
123246212903631369511
123561712926681373470
123903912940481377611
124089812958634001730
124426212976704006506
124615512991664014211
12510201300520
Vaxcel Port with PASV Titanium Mini-Port With PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm)
Navilyst Medical Logo. Follow link for full printed address.
45-215M001452150
119395212423091316807
119422912442631319163
119457912455411323431
119842112470371325747
119971812484311330396
120216712539401333308
120353412570221336009
120868212581021340118
120989512595161343198
121059412637111346938
121435312643231347894
121435412657701351419
121464912676901354064
121500012681341355339
121684912726621359540
121838812744101361868
121902312764201364432
121991412783391366291
122017212815701368296
122087112825821369512
122594012851441371077
122699912870971372172
122841212886481372901
122980012921581373965
123045712940491374540
123071612958641375756
123246312981071377315
123353213001174000285
123531913041464001731
123654713073554003056
123904013092614006508
123932013105034007735
124003513134674014212
4014213
Vaxcel Port with PASV Titanium Mini-Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm)
Navilyst Medical Logo.
45-220M001452200
119395312484321311034
119531112505271313096
119810412525851313097
120070012570231348374
120245712581031353274
120461412637121355601
120734012657711356197
120766412676911365529
121435512739011367037
121465012776331368843
121565712810301370103
121685012851451372521
122119112886491374541
122700012940481377316
122841312944801377612
123114312958651377844
123246412961411378093
123532012967091378345
123904112979231380085
123932113005211381887
124089913073564000284
124426413073574001732
124703813073584007724
4014661
Vaxcel Port Titanium Mini-Port with 6F Polyurethane Catheter (1.1 mm/1.9 mm)
Navilyst Medical Logo.
45-303M001453030
12676921320987
12832421327651
12845661344772
12900251359287
12964101366292
13005241370777
13069631377613
13125904001733
Vaxcel Port Titanium Mini-Port with 7F Polyurethane Catheter (1.3 mm/2.2 mm)
Navilyst Medical Logo.
45-305M001453050
12637131302380
12676931309262
12832431310743
12876051319164
12928651323675
12998601357022
1372173
Vaxcel Port Titanium Mini-Port with 8F Silicone Catheter (1.5 mm/2.6 mm)
Navilyst Medical Logo.
45-310M001453100
126371412860801321707
126477512870981345647
126769412886501346950
126971412926691354323
127232012944811355340
127369912950721359541
127550212976711360401
127659812995941364170
128324413012921367275
128410013100321373685
128514613123221381270
128540013168084001734
Vaxcel Port Titanium Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm)
Navilyst Medical Logo.
45-315M001453150
12643241294761
12774621304148
12883051320497
1356811
Vaxcel Port Titanium Standard Port with 8F Silicone Catheter (1.5 mm/2.6 mm)
Navilyst Medical Logo.
45-320M0014532001264960 1283246 1342235 1371638
Vaxcel Port Plastic Standard Port with 8F Silicone Catheter (1.5 mm/2.6 mm)
Navilyst Medical Logo.
45-340M0014534001263715 1277463 1294482 1332871
Vaxcel Port Plastic Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm)
Navilyst Medical Logo.
45-360M0014536001267697 1290638 1317254 1342462 1362918
Vaxel Port with PASV Titanium Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm)
Navilyst Medical Logo.
45-362M001453620
119233212525861341521
119810612570281349623
120217212581071351954
120495612621111357024
120689512655361359288
120868412676981362390
121435912681351363949
121465112752161365530
121966612783431371855
122790412863591373199
123005612886511374542
123114412928661377845
123399312958661379701
123966513059784001736
124325313083084007727
124554513149934010947
124843613212141282267D
12512341329618
Vaxcel Port with PASV Titanium Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm)
Navilyst Medical Logo.
45-364M001453640
119395712432541296998
119810712501351299862
119842312525871307903
119945412570291311285
120070112584241316268
120636212668101334583
121436012676991351212
122433312773081354065
122841812783441355341
122980312851471365531
123904412855941367038
124003712894761370574
4007741
Vaxcel Port w PASV Plastic Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm)
Navilyst Medical Logo.
45-366M001453660
119395812501361327177
119810812570301332149
120495712607601336928
121436112637161341264
121685112677001344773
122341312718961347895
122563112783451353759
122763112787991356587
122841912817541359289
122980412851481362391
123114512903641363950
123287012940501366735
123399412974261372174
123532113059791373686
123904513073591376248
123966613087671380992
124325513116904001737
124704013182144010940
4014270
Vaxcel Port with PASV Plastic Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm)
Navilyst Medical Logo.
45-368M001453680
119233412442651285401
119273912484371290026
119810912525881290639
120103112570311292159
121465212581081294051
121685212610211294762
121966712655371295867
122980512659951296142
123287112677011302934
123561812701351305980
123904612755031307360
123932312765991334584
124426512776341364172
123904612815714000283
12393231285149

BOSTON SCIENTIFIC PRODUCTS

ProductCatalog NumberUPN NumberLot Number
Vaxcel Port with PASV Titanium Mini-Port with PASV Valve and 6F Polyurethane Catheter (1.1 mm/1.9 mm)
Boston Scientific Logo. Follow link for full address.
45-213M001452130
119232712324621267689
119422812356171271309
119810312390391273698
119971712408981276597
120069912442621280329
120353312461551285143
121435212510201286832
121464812525841290363
121565612581011292668
121902212590571294048
122562712637101295863
122841112668091297670
Vaxcel Port with PASV Titanium Mini-Port With PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm)
Boston Scientific Logo. Follow link for full address.
45-215M001452150
119395212199141244263
119422912201721245541
119457912208711247037
119842112259401248431
119971812269991253940
120216712284121257022
120353412298001259516
120868212304571263711
120989512307161264323
121059412324631265770
121435312335321267690
121435412353191268134
121464912365471288648
121500012390401292158
121684912393201295864
121838812400351300117
12190231242309
Vaxcel Port with PASV Titanium Mini-Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm)
Boston Scientific Logo.
45-220M001452200
119395312270001258103
119531112284131265771
119810412311431267691
120070012324641273901
120245712353201277633
120461412390411281030
120734012393211285145
120766412408991288649
121435512442641294480
121465012470381295865
121565712484321296141
121685012505271296709
122119112525851297923
Vaxcel Port Titanium Mini-Port with 6F Polyurethane Catheter (1.1 mm/1.9 mm)
Boston Scientific Logo. Follow link for full address.
45-303M0014530301284566
Vaxcel Port Titanium Mini-Port with 8F Silicone Catheter (1.5 mm/2.6 mm)
Boston Scientific Logo. Follow link for full address.
45-310M0014531001273699 1285400 1286080 1287098
Vaxcel Port Titanium Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm)
Boston Scientific Logo. Follow link for full address.
45-315M0014531501294761
Vaxel Port with PASV Titanium Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm)
Boston Scientific Logo. Follow link for full address.
45-362M001453620
119233212279041252586
119810612300561267698
120217212311441268135
120495612339931278343
120689512396651286359
120868412432531295866
121435912455451305978
121465112484361282267D
12196661251234
Vaxcel Port with PASV Titanium Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm)
Boston Scientific Logo. Follow link for full address.
45-364M001453640
119395712432541267699
119810712501351277308
119842312525871285147
119945412570291296998
12007011258424
Vaxcel Port w PASV Plastic Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm)
Boston Scientific Logo. Follow link for full address.
45-366M001453660
119395812311451260760
119810812328701263716
120495712339941267700
121436112353211278345
121685112390451278799
122341312396661281754
122563112432551285148
122763112470401290364
122841912501361294050
122980412570301297426
Vaxcel Port with PASV Plastic Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm)
Boston Scientific Logo. Follow link for full address.
45-368M001453680
119233412442651281571
119273912390461285149
119810912393231285401
120103112442651290026
121465212484371290639
121685212525881292159
121966712610211294051
122980512655371294762
123287112677011295867
123561812701351296142
123904612765991302934
123932312776341305980

Navilyst Medical

Legal Manufacturer
Navilyst Medical, Inc.
26 Forest Street
Marlborough, MA 01752 USA
USA customer Service 800 833-9973

Made in the USA
10 Glens Falls Technical Park
Glens Falls, NY 12801 USA

Boston Scientific
Medi-Tech®

Boston Scientific Corporation
One Boston Scientific Place
Natick, MA 01760-1537
USA
USA Customer Service 888 272-1001

    
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