• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail

Multi-Med, Inc., 22 Gauge x 1 inch Straight and Right Angle Huber Needles and Navilyst Medical Inc., Vaxcel Implantable Vascular Access Systems Containing Huber Needles (Two Class I Recalls)

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

Product Catalog Number UPN Number Lot 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.
45-213 M001452130
1192327 1252584 1303564
1194228 1258101 1307354
1198103 1259057 1307625
1199717 1263710 1308513
1200699 1266809 1313095
1203533 1267689 1316267
1214352 1271309 1343197
1214648 1273698 1346939
1215656 1276597 1354063
1219022 1280329 1360019
1225627 1285143 1364758
1228411 1286832 1365528
1232462 1290363 1369511
1235617 1292668 1373470
1239039 1294048 1377611
1240898 1295863 4001730
1244262 1297670 4006506
1246155 1299166 4014211
1251020 1300520  
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.
45-215 M001452150
1193952 1242309 1316807
1194229 1244263 1319163
1194579 1245541 1323431
1198421 1247037 1325747
1199718 1248431 1330396
1202167 1253940 1333308
1203534 1257022 1336009
1208682 1258102 1340118
1209895 1259516 1343198
1210594 1263711 1346938
1214353 1264323 1347894
1214354 1265770 1351419
1214649 1267690 1354064
1215000 1268134 1355339
1216849 1272662 1359540
1218388 1274410 1361868
1219023 1276420 1364432
1219914 1278339 1366291
1220172 1281570 1368296
1220871 1282582 1369512
1225940 1285144 1371077
1226999 1287097 1372172
1228412 1288648 1372901
1229800 1292158 1373965
1230457 1294049 1374540
1230716 1295864 1375756
1232463 1298107 1377315
1233532 1300117 4000285
1235319 1304146 4001731
1236547 1307355 4003056
1239040 1309261 4006508
1239320 1310503 4007735
1240035 1313467 4014212
    4014213
Vaxcel Port with PASV Titanium Mini-Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm)
Navilyst Medical Logo.
45-220 M001452200
1193953 1248432 1311034
1195311 1250527 1313096
1198104 1252585 1313097
1200700 1257023 1348374
1202457 1258103 1353274
1204614 1263712 1355601
1207340 1265771 1356197
1207664 1267691 1365529
1214355 1273901 1367037
1214650 1277633 1368843
1215657 1281030 1370103
1216850 1285145 1372521
1221191 1288649 1374541
1227000 1294048 1377316
1228413 1294480 1377612
1231143 1295865 1377844
1232464 1296141 1378093
1235320 1296709 1378345
1239041 1297923 1380085
1239321 1300521 1381887
1240899 1307356 4000284
1244264 1307357 4001732
1247038 1307358 4007724
    4014661
Vaxcel Port Titanium Mini-Port with 6F Polyurethane Catheter (1.1 mm/1.9 mm)
Navilyst Medical Logo.
45-303 M001453030
1267692 1320987
1283242 1327651
1284566 1344772
1290025 1359287
1296410 1366292
1300524 1370777
1306963 1377613
1312590 4001733
Vaxcel Port Titanium Mini-Port with 7F Polyurethane Catheter (1.3 mm/2.2 mm)
Navilyst Medical Logo.
45-305 M001453050
1263713 1302380
1267693 1309262
1283243 1310743
1287605 1319164
1292865 1323675
1299860 1357022
  1372173
Vaxcel Port Titanium Mini-Port with 8F Silicone Catheter (1.5 mm/2.6 mm)
Navilyst Medical Logo.
45-310 M001453100
1263714 1286080 1321707
1264775 1287098 1345647
1267694 1288650 1346950
1269714 1292669 1354323
1272320 1294481 1355340
1273699 1295072 1359541
1275502 1297671 1360401
1276598 1299594 1364170
1283244 1301292 1367275
1284100 1310032 1373685
1285146 1312322 1381270
1285400 1316808 4001734
Vaxcel Port Titanium Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm)
Navilyst Medical Logo.
45-315 M001453150
1264324 1294761
1277462 1304148
1288305 1320497
  1356811
   
Vaxcel Port Titanium Standard Port with 8F Silicone Catheter (1.5 mm/2.6 mm)
Navilyst Medical Logo.
45-320 M001453200 1264960 1283246 1342235 1371638
Vaxcel Port Plastic Standard Port with 8F Silicone Catheter (1.5 mm/2.6 mm)
Navilyst Medical Logo.
45-340 M001453400 1263715 1277463 1294482 1332871
Vaxcel Port Plastic Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm)
Navilyst Medical Logo.
45-360 M001453600 1267697 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.
45-362 M001453620
1192332 1252586 1341521
1198106 1257028 1349623
1202172 1258107 1351954
1204956 1262111 1357024
1206895 1265536 1359288
1208684 1267698 1362390
1214359 1268135 1363949
1214651 1275216 1365530
1219666 1278343 1371855
1227904 1286359 1373199
1230056 1288651 1374542
1231144 1292866 1377845
1233993 1295866 1379701
1239665 1305978 4001736
1243253 1308308 4007727
1245545 1314993 4010947
1248436 1321214 1282267D
1251234 1329618  
Vaxcel Port with PASV Titanium Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm)
Navilyst Medical Logo.
45-364 M001453640
1193957 1243254 1296998
1198107 1250135 1299862
1198423 1252587 1307903
1199454 1257029 1311285
1200701 1258424 1316268
1206362 1266810 1334583
1214360 1267699 1351212
1224333 1277308 1354065
1228418 1278344 1355341
1229803 1285147 1365531
1239044 1285594 1367038
1240037 1289476 1370574
    4007741
Vaxcel Port w PASV Plastic Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm)
Navilyst Medical Logo.
45-366 M001453660
1193958 1250136 1327177
1198108 1257030 1332149
1204957 1260760 1336928
1214361 1263716 1341264
1216851 1267700 1344773
1223413 1271896 1347895
1225631 1278345 1353759
1227631 1278799 1356587
1228419 1281754 1359289
1229804 1285148 1362391
1231145 1290364 1363950
1232870 1294050 1366735
1233994 1297426 1372174
1235321 1305979 1373686
1239045 1307359 1376248
1239666 1308767 1380992
1243255 1311690 4001737
1247040 1318214 4010940
    4014270
Vaxcel Port with PASV Plastic Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm)
Navilyst Medical Logo.
45-368 M001453680
1192334 1244265 1285401
1192739 1248437 1290026
1198109 1252588 1290639
1201031 1257031 1292159
1214652 1258108 1294051
1216852 1261021 1294762
1219667 1265537 1295867
1229805 1265995 1296142
1232871 1267701 1302934
1235618 1270135 1305980
1239046 1275503 1307360
1239323 1276599 1334584
1244265 1277634 1364172
1239046 1281571 4000283
1239323 1285149  

BOSTON SCIENTIFIC PRODUCTS

Product Catalog Number UPN Number Lot 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.
45-213 M001452130
1192327 1232462 1267689
1194228 1235617 1271309
1198103 1239039 1273698
1199717 1240898 1276597
1200699 1244262 1280329
1203533 1246155 1285143
1214352 1251020 1286832
1214648 1252584 1290363
1215656 1258101 1292668
1219022 1259057 1294048
1225627 1263710 1295863
1228411 1266809 1297670
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.
45-215 M001452150
1193952 1219914 1244263
1194229 1220172 1245541
1194579 1220871 1247037
1198421 1225940 1248431
1199718 1226999 1253940
1202167 1228412 1257022
1203534 1229800 1259516
1208682 1230457 1263711
1209895 1230716 1264323
1210594 1232463 1265770
1214353 1233532 1267690
1214354 1235319 1268134
1214649 1236547 1288648
1215000 1239040 1292158
1216849 1239320 1295864
1218388 1240035 1300117
1219023 1242309  
Vaxcel Port with PASV Titanium Mini-Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm)
Boston Scientific Logo.
45-220 M001452200
1193953 1227000 1258103
1195311 1228413 1265771
1198104 1231143 1267691
1200700 1232464 1273901
1202457 1235320 1277633
1204614 1239041 1281030
1207340 1239321 1285145
1207664 1240899 1288649
1214355 1244264 1294480
1214650 1247038 1295865
1215657 1248432 1296141
1216850 1250527 1296709
1221191 1252585 1297923
Vaxcel Port Titanium Mini-Port with 6F Polyurethane Catheter (1.1 mm/1.9 mm)
Boston Scientific Logo. Follow link for full address.
45-303 M001453030 1284566
Vaxcel Port Titanium Mini-Port with 8F Silicone Catheter (1.5 mm/2.6 mm)
Boston Scientific Logo. Follow link for full address.
45-310 M001453100 1273699 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.
45-315 M001453150 1294761
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.
45-362 M001453620
1192332 1227904 1252586
1198106 1230056 1267698
1202172 1231144 1268135
1204956 1233993 1278343
1206895 1239665 1286359
1208684 1243253 1295866
1214359 1245545 1305978
1214651 1248436 1282267D
1219666 1251234  
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.
45-364 M001453640
1193957 1243254 1267699
1198107 1250135 1277308
1198423 1252587 1285147
1199454 1257029 1296998
1200701 1258424  
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.
45-366 M001453660
1193958 1231145 1260760
1198108 1232870 1263716
1204957 1233994 1267700
1214361 1235321 1278345
1216851 1239045 1278799
1223413 1239666 1281754
1225631 1243255 1285148
1227631 1247040 1290364
1228419 1250136 1294050
1229804 1257030 1297426
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.
45-368 M001453680
1192334 1244265 1281571
1192739 1239046 1285149
1198109 1239323 1285401
1201031 1244265 1290026
1214652 1248437 1290639
1216852 1252588 1292159
1219667 1261021 1294051
1229805 1265537 1294762
1232871 1267701 1295867
1235618 1270135 1296142
1239046 1276599 1302934
1239323 1277634 1305980

Addresses

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