Huber Needles From Multi-Med, Inc., & Navilyst Medical Inc., Recalled

AUDIENCE: Risk Manager, Surgery, Critical Care Medicine
ISSUE: FDA notified healthcare professionals of the Class I Recall of certain Huber needles that were determined by FDA testing to produce cores when inserted into ports. Coring may lead to 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.
BACKGROUND: Following hospital reports to the FDA of leakage after accessing the port with a Huber needle (labeled to be non-coring), FDA conducted its own laboratory testing of Huber needles from multiple manufacturers. 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.
RECOMMENDATION: Clinicians should immediately discontinue use of the recalled products. If you must use the kit, consider using an alternative, unaffected non-coring needle if possible.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[08/26/2010 - Recall Notice - FDA] See Below;
Previous MedWatch Alert:
[01/26/2010 - Recall Notice - FDA]

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:

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

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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)	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)	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)	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)	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)	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)	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)	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)	45-320	M001453200	1264960 1283246 1342235 1371638
Vaxcel Port Plastic Standard Port with 8F Silicone Catheter (1.5 mm/2.6 mm)	45-340	M001453400	1263715 1277463 1294482 1332871
Vaxcel Port Plastic Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm)	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)	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)	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)	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)	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)	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)	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)	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)	45-303	M001453030	1284566
Vaxcel Port Titanium Mini-Port with 8F Silicone Catheter (1.5 mm/2.6 mm)	45-310	M001453100	1273699 1285400 1286080 1287098
Vaxcel Port Titanium Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm)	45-315	M001453150	1294761
Vaxel Port with PASV Titanium Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm)	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)	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)	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)	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