—#188744

Product

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

FDA product code: FMI — Needle, Hypodermic, Single Lumen
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K930217
Affected 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

Why it was recalled

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

Root cause (FDA determination)

Packaging change control

Action the firm took

On August 4, 2021, Bard Peripheral Vascular, Inc. issued an "Urgent Medical device Correction" notice to affected customers via Fed Ex. In addition to informing consignees about the recall product, BD ask consignees to take the following actions: 1. Please check all inventory locations within your institution for the product listed in Attachment A and immediately destroy all affected product remaining in your possession. The product should have the sterile barrier broken and destroyed per your local facility s destruction process. 2. Share this notice with any users of the product within your facilities to ensure they are also aware of this Urgent Medical Device Correction. 3. If you purchased this product from a distributor, contact your distributor for further instructions. 4. Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the correction notification, whether or not you have any affected product, so that BD may acknowledge your receipt of this notification and process your credit. 5. Please contact your BD representative to assist in this process or you may also contact the number below for further assistance. 6. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fisher s Lane, Rockville, MD 20852-9787 7. BD Contact Information: If you require further assistance please contact: North American Regional Complaint Center, 1-844-8BD- LIFE (1-844-823-5433) Say Recall when prompted, M-F 8am - 5pm CT, Recall Questions, Product Complaints, Technical Questions

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Bldg 1, Tempe, Arizona 85281-2438

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2021-07-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188744. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.