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Class 2 Device Recall Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle |
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| Date Initiated by Firm |
July 27, 2021 |
| Create Date |
October 01, 2021 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0002-2022 |
| Recall Event ID |
88473 |
| 510(K)Number |
K930217
|
| Product Classification |
Needle, hypodermic, single lumen - Product Code FMI
|
| Product |
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796 |
| Code Information |
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 |
Recalling Firm/
Manufacturer |
Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
Tempe AZ 85281-2438
|
| For Additional Information Contact |
North American Regional Complaint Center
1844-823-5433
|
Manufacturer Reason
for Recall |
Potential for needle protector to become fully dislodge exposing infusion needle which could result in needle stick.
|
FDA Determined
Cause 2 |
Packaging change control |
| Action |
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 |
| 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.
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| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database |
510(K)s with Product Code = FMI and Original Applicant = BAXTER HEALTHCARE CORP.
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