Class II Recall

REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 1088

Summary

The FDA issued a Class II for REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, Fo by Bard Peripheral Vascular Inc. Reason: Potential for needle protector to become fully dislodge exposing infusion needle which could result in needle stick..

Details

Source

Device Recall

External ID

Z-0002-2022

Action Date

2021-10-13

Status

Ongoing

Product Description

REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

Lot/Code Info: Lot/Serial Number - Exp. Date: 963162 6/30/2021; 967672 6/30/2021; 978229 7/31/2021; 986594 7/31/2021; 988075 7/31/2021; 991067 8/31/2021; 994373 8/31/2021; 996570 8/31/2021; 998004 8/31/2021; 998332 8/31/2021; 1000061 8/31/2021; 1004858 9/30/2021; 1005204 9/30/2021; 1007650 9/30/2021; 1010791 9/30/2021; 1013939 9/30/2021; 1017379 10/31/2021; 1035580 11/30/2021; 1035581 11/30/2021; 1038740 11/30/2021; 1044131 12/31/2021; 1049259 12/31/2021; 1050881 12/31/2021; 1052628 12/31/2021; 1057742 1/31/2022; 1059045 1/31/2022; 1061515 1/31/2022; 1065338 1/31/2022; 1066413 1/31/2022; 1066484 1/31/2022; 1068754 2/28/2022; 1069385 2/28/2022; 1072036 2/28/2022; 1072932 2/28/2022; 1076214 2/28/2022; 1078134 2/28/2022; 1078406 2/28/2022; 1080547 2/28/2022; 1082456 2/28/2022; 1085984 3/31/2022; 1086606 3/31/2022; 1087768 3/31/2022; 1088480 3/31/2022; 1089329 3/31/2022; 1089500 3/31/2022; 1090412 3/31/2022; 1092057 3/31/2022; 1094384 3/31/2022; 1095382 4/30/2022; 1097231 4/30/2022; 1097282 4/30/2022; 1098267 4/30/2022; 1099427 4/30/2022; 1102009 4/30/2022; 1109455 5/31/2022; 1110142 5/31/2022; 1112821 5/31/2022; 1113754 5/31/2022; 1116187 5/31/2022; 1121054 5/31/2022; 1122273 6/30/2022; 1125711 6/30/2022; 1125917 6/30/2022; 1127492 6/30/2022; 1127964 6/30/2022; 1129544 6/30/2022; 1130696 6/30/2022; 1132694 6/30/2022; 1137174 7/31/2022; 1138050 7/31/2022; 1142149 7/31/2022; 1143470 7/31/2022; 1143855 7/31/2022; 1144660 7/31/2022; 1146743 7/31/2022; 1150183 8/31/2022; 1151530 8/31/2022; 1152049 8/31/2022; 1152438 8/31/2022; 1153264 8/31/2022; 1155379 8/31/2022; 1155518 8/31/2022; 1155992 8/31/2022; 1158661 8/31/2022; 1159859 8/31/2022; 1161713 9/30/2022; 1164223 9/30/2022; 1166044 9/30/2022; 1167036 9/30/2022; 1167227 9/30/2022; 1167956 9/30/2022; 1169993 9/30/2022; 1180039 10/31/2022; 1189176 11/30/2022; 1190023 11/30/2022; 1190032 11/30/2022; 1194421 11/30/2022; 1194422 11/30/2022; 1198084 12/31/2022; 1198085 12/31/2022; 1200458 12/31/2022; 1200657 12/31/2022; 1202859 12/31/2022; 1204663 12/31/2022; 1206730 12/31/2022; 1209231 12/31/2022; 1210383 1/31/2023; 1210987 1/31/2023; 1213059 1/31/2023; 1214083 1/31/2023; 1214808 1/31/2023; 1217214 2/28/2023; 1218641 2/28/2023; 1220580 2/28/2023; 1221532 2/28/2023; 1230001 3/31/2023; 1234242 4/30/2023; 1234866 4/30/2023; 1237066 4/30/2023; 1239250 4/30/2023; 1241484 5/31/2023; 1243238 5/31/2023; 1245024 5/31/2023; 1250142 6/30/2023; 1253967 7/31/2023; 1255153 7/31/2023; 1256826 7/31/2023; 1257665 7/31/2023; 1260624 8/31/2023; 1261698 8/31/2023; 1263690 8/31/2023; 1268443 9/30/2023; 1269717 9/30/2023; 1276374 11/30/2023; 1276474 11/30/2023; 1277076 11/30/2023; 1277078 11/30/2023; 1278052 11/30/2023; 1279629 12/31/2023; 1280551 12/31/2023; 1281423 12/31/2023; 1282441 12/31/2023; 1282566 12/31/2023; 1285959 1/31/2024; 1289325 1/31/2024; 1290116 2/29/2024; 1290526 2/29/2024; 1290901 2/29/2024; 1291368 2/29/2024; 1291991 2/29/2024; 1293285 2/29/2024; 1293713 2/29/2024; 1294738 3/31/2024; 1296369 3/31/2024; 1297347 3/31/2024; 1298132 3/31/2024; 1299347 4/30/2024; 1302001 4/30/2024; 1302770 4/30/2024; 1304508 4/30/2024; 1305180 5/31/2024; 1306210 5/31/2024; 1306618 6/30/2024; 1307348 5/31/2024; 1308370 5/31/2024; 1309271 6/30/2024; 1310700 6/30/2024; 1312765 6/30/2024; 1313035 6/30/2024; 1313638 6/30/2024; 1315612 7/31/2024; 1319007 8/31/2024; 1321484 8/31/2024; 1321909 8/31/2024; 1323424 9/30/2024; 1324561 9/30/2024; 1325914 9/30/2024; 1326666 9/30/2024; 1328546 10/31/2024; 1328868 10/31/2024; 1330383 10/31/2024; 1331229 11/30/2024; 1334317 11/30/2024; 1335560 11/30/2024; 1336948 12/31/2024; 1346946 2/28/2025; 1350086 2/28/2025; 1352112 2/28/2025; 1353076 2/28/2025; 1354658 3/31/2025; 1355795 3/31/2025; 1356579 3/31/2025; 1364166 5/31/2025; 1370390 6/30/2025; 1371002 6/30/2025; 1372716 6/30/2025; 1372717 6/30/2025; 1373632 6/30/2025; 1374321 6/30/2025; 1374720 6/30/2025; 1376484 7/31/2025; 1376558 7/31/2025; 1378293 7/31/2025; 1379114 7/31/2025; 1379319 7/31/2025; 1379975 7/31/2025; 1380313 7/31/2025; 1382427 8/31/2025; 1382905 8/31/2025; 1383730 8/31/2025; 1384557 8/31/2025; 1389054 9/30/2025; 1389688 9/30/2025; 1389835 9/30/2025; 1390329 10/31/2025; 1392449 10/31/2025; 1392925 10/31/2025; 1393712 10/31/2025; 1395327 11/30/2025; 1396203 11/30/2025; 1397019 11/30/2025; 1397577 11/30/2025; 1397579 11/30/2025; 1399709 12/31/2025; 1401245 1/31/2026; 1402635 1/31/2026; 1403128 1/31/2026; 1404960 1/31/2026; 1405506 1/31/2026; 1408600 2/28/2026; 1409355 2/28/2026; 1411640 3/31/2026; 1412991 3/31/2026; 1414301 4/30/2026; 1414832 4/30/2026; 1416059 4/30/2026; 1417013 4/30/2026; 1418166 4/30/2026; 1418927 5/31/2026; 1419365 5/31/2026; 1420607 5/31/2026

Reason for Recall

Potential for needle protector to become fully dislodge exposing infusion needle which could result in needle stick.

Distribution

Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WV and the countries of Netherlands, United Arab Emirates, Australia, Taiwan, Asia, South Africa, Canada, JAPAN, India, Hong Kong, New Zealand, Mexico, China, Belgium, Malaysia, Singapore, Vietnam.

Type: Voluntary: Firm initiated

Recall Initiated: 2021-07-27

Company

Bard Peripheral Vascular Inc

Tempe, AZ

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 192 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Bard Peripheral Vascular Inc has 42 FDA actions in our database, including 33 recalls and 9 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bard Peripheral Vascular Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Bard Peripheral Vascular Inc have FDA actions?

Bard Peripheral Vascular Inc has 42 FDA actions in our database, including 33 recalls and 9 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-0002-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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