Arrow International Inc: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.

Agency Publication Date: January 24, 2020

Affected Products

Product: FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501

Lots: 23F19A0301 23F19F0108 23F19F0481 23F19H0079 23F19J0305 23F19L0094 23F19C0303 23F19F0297 23F19G0039 23F19H0145 23F19J0484 23F19L0209 23F19D0266 23F19F0388 23F19G0263 23F19H0386 23F19K0171 23F19M0112

Product: EPIDURAL CATHETERIZATION KIT, Product Code ALZANO-05400-B

Lots: 71F19B0681 71F19C0035 71F19D2827 71F19F2028 71F19H1633 71F19K1574

Product: FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH

Lots: 13F19F0303 13F19G0072 13F19L0140

Product: TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1

Lots: 23F18M0499 23F19F0164 23F19H0109 23F19L0471 23F19C0409 23F19G0535 23F19K0082

Product: FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05500-TM

Lots: 23F19E0116 23F19G0501 23F19K0188

Product: FlexTip Plus Epidural Catheterization Kit, Product Code AK-05500

Lots: 13F19G0085 13F19H0381

Product: FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05500-BID

Lots: 23F19E0337 23F19J0065 23F19K0100 23F19L0218 23F19H0048 23F19J0314 23F19K0303 23F19M0007

Product: FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1

Lots: 13F19B0343 13F19B0501 13F19E0698 13F19H0470

Product: FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05501-SH

Lots: 23F19A0240 23F19G0305 23F19J0292 23F19L0414 23F19E0112 23F19G0496 23F19K0152

Product: Epidural Catheterization Kit with FlexTip Plus, Open Tip, Single- Port Catheter, Product Code ASK-05502-NY

Lots: 23F19C0385 23F19G0310 23F19H0234 23F19K0248 23F19F0167 23F19G0434 23F19J0063

Product: FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05503-BID

Lots: 23F19G0306 23F19H0035 23F19K0149 23F19L0411

Product: FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-TG1

Lots: 23F19A0154 23F19C0273 23F19F0029 23F19G0360 23F19M0226

Product: FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-WH

Lots: 13F18L0892 13F19C0478 13F19E0433 13F19K0051 13F19B0588 13F19D0327 13F19H0209 13F19L0079

Product: FlexTip Plus Epidural Catheterization Kit, Product Code ASK-17019-MSC

Lots: 13F18K0094 13F19B0335 13F19C0594 13F19G0068 13F19G0591 13F19J0119

Product: EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LEO

Lots: 71F19B0740 71F19C1369 71F19G1023 71F19J1434 71F19C0033 71F19E1660 71F19H1350

Product: EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LIN

Lots: 71F19C1431 71F19H1811 71F19K1515

Product: EPIDURAL CATHETERIZATION KIT, Product Code BE-05400B-ETTEL

Lots: 71F19C0509 71F19G0116 71F19H1409 71F19J1840 71F19D2945 71F19G2238 71F19J0078

Product: EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCHH

Lots: 71F19D0610 71F19G2151

Product: EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCSHO

Lots: 71F19C0983 71F19D0315 71F19E1828 71F19H1445 71F19J1822 71F19K1828

Product: EPIDURAL CATHETERIZATION KIT, Product Code BE-080180-BXL

Lots: 71F19B0729 71F19E2327 71F19G1496 71F19J1005 71F19C1089 71F19F0733 71F19H0793

Product: EPIDURAL CATHETERIZATION KIT, Product Code BE-080180-CHH

Lots: 71F19D0608 71F19F1570 71F19H2423 71F19K1108 71F19E2537 71F19G2485 71F19J1513

Product: FlexTip Plus Epidural Catheterization Kit, Product Code CA-02220

Lots: 13F18J0481 13F19D0441 13F19E0237 13F19K0136 13F19L0363 13F19A0671 13F19D0671 13F19G0613 13F19K0544

Product: EPIDURAL CATHETERIZATION KIT, Product Code CZ-05400-EPI

Lots: 71F19B0663 71F19E2004 71F19G2408 71F19K2838 71F19C0095 71F19G0885 71F19H1697

Product: EPIDURAL CATHETERIZATION KIT, Product Code DE-05400D-BO

Lots: 71F19D2769 71F19H0716 71F19K1690

Product: FlexTip Plus Epidural Catheterization Set for Pediatric Lumbar Placement, Product Code EC-05520-P

Lots: 71F19B2227 71F19E1297 71F19G1231 71F19G2158 71F19H2674 71F19J0430

Product: EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04

Lots: 71F19B0678 71F19C1428 71F19E1149 71F19G0313 71F19J0072 71F19L0492 71F19B2751 71F19D0558 71F19E1781 71F19G2388 71F19J1370 71F19L0493 71F19C0778 71F19D2449 71F19F0737 71F19H1817 71F19K2849

Product: EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-10

Lots: 71F19B1457 71F19D1662 71F19G0145 71F19H2708 71F19K2670 71F19C1527 71F19E1145 71F19G2429 71F19J1367 71F19C2577 71F19E2862 71F19H1833 71F19K0948

Product: EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-12

Lots: 71F19A0623 71F19C1042 71F19E1144 71F19G2853 71F19K0248 71F19A2996 71F19C2596 71F19E2950 71F19H2549 71F19K2117 71F19B1149 71F19D2545 71F19G1138 71F19J1815 71F19L0436

Product: EPIDURAL CATHETERIZATION KIT, Product Code IT-05400-DC

Lots: 71F19B2176 71F19C0468 71F19G1135 71F19L1545

Product: FlexTip Plus Epidural Catheterization Set, Product Code AA-05400-E

Lots: 71F19B2081 71F19C1655 71F19E2128 71F19G2444 71F19B2586 71F19E1245 71F19F1432 71F19J1685

Product: FlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code AA-05400-B

Lots: 71F19E2457 71F19G0988 71F19H1281 71F19K2009 71F19F1658 71F19G2371 71F19J1079

Product: FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-B

Lots: 71F19A0552 71F19C0531 71F19D1772 71F19F0481 71F19G2970 71F19K1979 71F19A1876 71F19C1329 71F19D2237 71F19F0794 71F19H1056 71F19K2381 71F19A2686 71F19C2027 71F19D2580 71F19F1426 71F19H1236 71F19K2382 71F19A2926 71F19C2239 71F19E0587 71F19F2006 71F19H1300 71F19L0281 71F19B0499 71F19C2723 71F19E0689 71F19G0494 71F19H2034 71F19L0502 71F19B1222 71F19C2866 71F19E1636 71F19G1028 71F19J0768 71F19L0653 71F19B2079 71F19D0056 71F19E2838 71F19G1720 71F19J1251 71F19B2664 71F19D0839 71F19E3183 71F19G2237 71F19J2203 71F19B2849 71F19D1511 71F19F0256 71F19G2837 71F19J2204

Product: FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-DCS

Lots: 71F19B0226 71F19B2848 71F19D0451 71F19E0081 71F19F0245 71F19J1235 71F19B0707 71F19C0406 71F19D0826 71F19E0998 71F19F0482 71F19J2164 71F19B0935 71F19C2047 71F19D1267 71F19E1253 71F19G1938 71F19K2878 71F19B1484 71F19C2433 71F19D2474 71F19E1315 71F19G2556 71F19B1832 71F19D0055 71F19D2761 71F19E2505 71F19H2404

Product: FlexTip Plus Epidural Catheterization Kit, Product Code JC-05400-E

Lots: 71F19A1623 71F19B0507 14F19D0467 71F19G0728 71F19J1893 14F19L0127 71F19A2295 14F19B0224 71F19E1270 71F19G0974 71F19K0694 71F19A2972 14F19D0011 71F19E1868 71F19J0168 71F19K0899 71F19B0343 71F19D2947 71F19F0330 14F19J0132 71F19K2112

Product: EPIDURAL CATHETERIZATION KIT, Product Code JC-05400-LB

Lots: 71F19B2180 71F19E1142 71F19F1082 71F19H2578 71F19E0149 71F19F1081 71F19G2551 71F19K1691

Product: 10 cc Luer-Slip Loss of Resistance Syringe, Product Code LR-05501

Lots: 13F18J0916 13F19C0321 13F19G0070 13F19H0274 13F19J0039 13F19L0252 13F18K0675 13F19D0335 13F19G0071 13F19H0275 13F19J0040 13F18L0737 13F19E0141 13F19G0458 13F19H0634 13F19J0596 13F18M0178 13F19E0212 13F19H0085 13F19J0038 13F19K0097

Product: FlexTip Plus Epidural Catheterization Set, Product Code MP-17019-TIP

Lots: 13F19A0544 13F19B0451 13F19E0017 13F19K0394 13F19A0796 13F19D0481 13F19G0086 13F19L0070

Product: FlexTip Plus Epidural Catheterization Kit, Product Code MP-17019-TKP

Lots: 23F19C0216 23F19F0037 23F19G0368 23F19J0089 23F19K0199 23F19M0018 23F19E0350 23F19F0269 23F19H0131 23F19J0208 23F19L0230

Product: EPIDURAL CATHETERIZATION KIT, Product Code MTO-05500-SU

Lots: 71F19D0624 71F19E0717 71F19F1173 71F19F1768 71F19L0352

Product: FlexTip Plus Epidural Catheterization Set, Product Code MTO-05500-TK

Lots: 71F19A2894 71F19B1150 71F19F0028 71F19G1441 71F19H1499

Product: EPIDURAL CATHETERIZATION KIT, Product Code MTO-09903-KU

Lots: 71F19B1406 71F19E2026 71F19G1921

Product: FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code NYU-05500-1

Lots: 23F19A0245 23F19G0253

Product: FlexTip Plus Epidural Catheterization Kit, Product Code TI-05501-ME

Lots: 71F19A1324 71F19C2255 71F19E3165 71F19H1740 71F19K0132 71F19B0614 71F19C2567 71F19G0092 71F19H1742 71F19K0134 71F19C2254 71F19E0766 71F19G1018 71F19H2570 71F19L0033

Product: Epidural Catheterization Kit with FlexTip Plus Catheter, Product Code TI-05520-EPI

Lots: 71F19E2613 71F19F1493

Product: EPIDURAL CATHETERIZATION KIT, Product Code UR-05501

Lots: 71F19C0040 71F19E1143 71F19G1454 71F19H2552 71F19C1116 71F19E2861 71F19H0787 71F19J0868

Product: EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-EXP

Lots: 71F19B0757 71F19D1493 71F19E2344 71F19G2640 71F19J0575 71F19C0748 71F19E0193 71F19G1146 71F19H2120 71F19K1689

Product: EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-FR1

Lots: 71F19B0757 71F19D1493 71F19E2344 71F19G2640 71F19J0575 71F19C0748 71F19E0193 71F19G1146 71F19H2120 71F19K1689

Product: FlexTip Plus Epidural Catheterization Kit, Product Code YC-02220

Lots: 13F19B0340 13F19E0025 13F19G0069 13F19H0066 13F19K0137 13F19K0582

Product: EPIDURAL CATHETERIZATION KIT, Product Code BJC-05400-BEN

Lots: 71F19A1610 71F19C1989 71F19F0568 71F19G2407 71F19K2654 71F19B0253 71F19E1613 71F19G0263 71F19H1828

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84726

Status: Resolved

Manufacturer: Arrow International Inc

Manufactured In: United States

Units Affected: 49 products (343105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total; 343,105 total)

Agency Last Updated: February 13, 2020

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products