Class 1 Device Recall ARROW Endurance Extended Dwell Peripheral Catheter System

• Date Initiated by Firm: May 19, 2023
• Date Posted: June 21, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1826-2023
• Recall Event ID: 92377
• 510(K)Number: K163513
• Product Classification: Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
• Product: ARROW Endurance Extended Dwell Peripheral Catheter System
• Code Information: a. Product Code: ASK-00620-MSH. UDI (Batch Number): (01)10801902212105 (17)240630 (11)220914 (10)13F22H0910 (13F22H0910), (01)10801902212105 (17)240630 (11)221118 (10)13F22L0492 (13F22L0492); b. Product Code: ASK-00620-TMC. UDI (Batch Number): (01)10801902193022 (17)230531 (10)13F21J0257 (13F21J0257), (01)10801902193022 (17)230731 (11)220511 (10)13F22E0014 (13F22E0014), (01)10801902193022 (17)230731 (11)220527 (10)13F22E0263 (13F22E0263), (01)10801902193022 (17)240229 (11)220729 (10)13F22G0191 (13F22G0191), (01)10801902193022 (17)240430 (11)221012 (10)13F22K0352 (13F22K0352), (01)10801902193022 (17)240430 (11)230113 (10)13F23A0220 (13F23A0220), (01)10801902193022 (17)240731 (11)230309 (10)33F23B1020 (33F23B1020); c. Product Code: ASK-00622-MSH. UDI (Batch Number): (01)10801902212112 (17)240630 (11)220909 (10)13F22H0912 (13F22H0912), (01)10801902212112 (17)240630 (11)221114 (10)13F22L0361 (13F22L0361); d. Product Code: ASK-00818-IVA. UDI (Batch Number): (01)10801902144499 (17)231031 (10)13F21L0242 (13F21L0242), (01)10801902144499 (17)240229 (11)220324 (10)13F22C0480 (13F22C0480); e. Product Code: ASK-00820-FLH. UDI (Batch Number): (01)10801902146318 (17)230630 (11)220124 (10)13F22A0808 (13F22A0808), (01)10801902146318 (17)230930 (11)220530 (10)13F22E0250 (13F22E0250), (01)10801902146318 (17)231231 (11)220606 (10)13F22F0034 (13F22F0034), (01)10801902146318 (17)240331 (11)221107 (10)13F22K1112 (13F22K1112), (01)10801902146318 (17)240331 (11)221122 (10)13F22L0530 (13F22L0530), (01)10801902146318 (17)240831 (11)230309 (10)33F23B1019 (33F23B1019); f. Product Code: ASK-00820-TMC. UDI (Batch Number): (01)10801902192988 (17)230731 (11)220309 (10)13F22B0679 (13F22B0679), (01)10801902192988 (17)230731 (11)220412 (10)13F22C0817 (13F22C0817), (01)10801902192988 (17)230731 (11)220527 (10)13F22E0442 (13F22E0442), (01)10801902192988 (17)230731 (11)220715 (10)13F22F0601 (13F22F0601), (01)10801902192988 (17)240229 (11)220924 (10)13F22J0341 (13F22J0341), (01)10801902192988 (17)240430 (11)221107 (10)13F22K1113 (13F22K1113), (01)10801902192988 (17)240430 (11)221114 (10)13F22L0266 (13F22L0266), (01)10801902192988 (17)240430 (11)221206 (10)13F22L0910 (13F22L0910), (01)10801902192988 (17)240731 (11)230309 (10)33F23B1025 (33F23B1025); g. Product Code: EDC-00620. UDI (Batch Number): (01)10801902132908 (17)230831 (10)14F18H0260 (14F18H0260), (01)10801902132908 (17)230831 (10)14F18H0451 (14F18H0451), (01)10801902132908 (17)200930 (10)14F18K0137 (14F18K0137), (01)10801902132908 (17)231031 (10)14F18L0078 (14F18L0078), (01)10801902132908 (17)201130 (10)14F18M0028 (14F18M0028), (01)10801902132908 (17)230531 (10)14F21E0292 (14F21E0292), (01)10801902132908 (17)230531 (10)14F21F0075 (14F21F0075), (01)10801902132908 (17)230531 (10)14F21F0129 (14F21F0129), (01)10801902132908 (17)230731 (10)14F21F0250 (14F21F0250), (01)10801902132908 (17)230731 (10)14F21G0240 (14F21G0240), (01)10801902132908 (17)230731 (10)14F21H0189 (14F21H0189), (01)10801902132908 (17)230831 (10)14F21H0220 (14F21H0220), (01)10801902132908 (17)230831 (10)14F21J0112 (14F21J0112), (01)10801902132908 (17)230930 (10)14F21J0169 (14F21J0169), (01)10801902132908 (17)230930 (10)14F21K0030 (14F21K0030), (01)10801902132908 (17)230930 (10)14F21K0053 (14F21K0053), (01)10801902132908 (17)231031 (10)14F21L0209 (14F21L0209), (01)10801902132908 (17)231031 (10)14F21L0210 (14F21L0210), (01)10801902132908 (17)231031 (10)14F21L0211 (14F21L0211), (01)10801902196368 (17)231231 (10)14F21M0098 (14F21M0098), (01)10801902196368 (17)231231 (10)14F21M0099 (14F21M0099), (01)10801902196368 (17)231231 (10)14F22A0008 (14F22A0008), (01)10801902196368 (17)240229 (10)14F22C0097 (14F22C0097), (01)10801902196368 (17)240229 (10)14F22C0098 (14F22C0098), (01)10801902196368 (17)240229 (10)14F22C0099 (14F22C0099), (01)10801902196368 (17)240229 (10)14F22C0100 (14F22C0100), (01)10801902196368 (17)240229 (10)14F22C0270 (14F22C0270), (01)10801902196368 (17)240331 (10)14F22C0271 (14F22C0271), (01)10801902196368 (17)240331 (10)14F22C0272 (14F22C0272), (01)10801902196368 (17)240331 (10)14F22D0083 (14F22D0083), (01)10801902196368 (17)240331 (10)14F22D0084 (14F22D0084), (01)10801902196368 (17)240430 (10)14F22E0009 (14F22E0009), (01)10801902196368 (17)240430 (10)14F22E0068 (14F22E0068), (01)10801902132908 (17)240430 (10)14F22E0125 (14F22E0125), (01)10801902196368 (17)240531 (10)14F22F0071 (14F22F0071), (01)10801902196368 (17)240630 (10)14F22F0333 (14F22F0333), (01)10801902196368 (17)240630 (10)14F22G0051 (14F22G0051), (01)10801902196368 (17)240630 (10)14F22G0052 (14F22G0052), (01)10801902196368 (17)240731 (10)14F22G0217 (14F22G0217), (01)10801902196368 (17)240731 (10)14F22G0218 (14F22G0218), (01)10801902196368 (17)240831 (10)14F22H0342 (14F22H0342), (01)10801902196368 (17)240930 (10)14F22J0279 (14F22J0279), (01)10801902196368 (17)240930 (10)14F22K0061 (14F22K0061), (01)10801902196368 (17)241031 (10)14F22K0210 (14F22K0210), (01)10801902196368 (17)241031 (10)14F22L0027 (14F22L0027), (01)10801902196368 (17)241031 (10)14F22L0028 (14F22L0028), (01)10801902196368 (17)241031 (10)14F22L0070 (14F22L0070), (01)10801902196368 (17)241031 (10)14F22L0071 (14F22L0071), (01)10801902196368 (17)241130 (10)14F22L0161 (14F22L0161), (01)10801902196368 (17)241231 (10)14F23A0058 (14F23A0058), (01)10801902196368 (17)241231 (10)14F23A0174 (14F23A0174), (01)10801902196368 (17)241231 (10)14F23A0175 (14F23A0175), (01)10801902196368 (17)241231 (10)14F23A0176 (14F23A0176), (01)10801902196368 (17)241231 (10)14F23A0177 (14F23A0177), (01)10801902196368 (17)241231 (10)14F23A0308 (14F23A0308), (01)10801902196368 (17)250131 (10)14F23B0201 (14F23B0201); h. Product Code: EDC-00620-B. UDI (Batch Number): (01)10801902133004 (17)230531 (10)13F21E0852 (13F21E0852), (01)10801902133004 (17)230531 (10)13F21F0212 (13F21F0212), (01)10801902133004 (17)230531 (10)13F21F0523 (13F21F0523), (01)10801902133004 (17)230630 (10)13F21G1197 (13F21G1197), (01)10801902133004 (17)230831 (10)13F21H1179 (13F21H1179), (01)10801902133004 (17)230831 (10)13F21J0282 (13F21J0282), (01)10801902133004 (17)230930 (10)13F21K0896 (13F21K0896), (01)10801902133004 (17)231130 (10)13F21M0122 (13F21M0122), (01)10801902133004 (17)231231 (10)13F22A0152 (13F22A0152), (01)10801902133004 (17)240229 (10)13F22B0677 (13F22B0677), (01)10801902133004 (17)240430 (10)13F22E0261 (13F22E0261), (01)10801902133004 (17)240630 (10)13F22G0196 (13F22G0196), (01)10801902133004 (17)240930 (10)13F22K0354 (13F22K0354), (01)10801902133004 (17)240930 (10)13F22K0563 (13F22K0563), (01)10801902133004 (17)241130 (11)221214 (10)13F22M0126 (13F22M0126), (01)10801902133004 (17)241231 (11)230105 (10)13F22M0468 (13F22M0468), (01)10801902133004 (17)250228 (11)230310 (10)33F23B1021 (33F23B1021); i. Product Code: EDC-00622. UDI (Batch Number): (01)10801902132922 (17)230531 (10)14F21D0276 (14F21D0276), (01)10801902132922 (17)230531 (10)14F21F0151 (14F21F0151), (01)10801902132922 (17)230630 (10)14F21G0117 (14F21G0117), (01)10801902132922 (17)230731 (10)14F21G0286 (14F21G0286), (01)10801902132922 (17)230831 (10)14F21H0218 (14F21H0218), (01)10801902132922 (17)230831 (10)14F21J0111 (14F21J0111), (01)10801902132922 (17)230930 (10)14F21K0051 (14F21K0051), (01)10801902132922 (17)231130 (10)14F21L0212 (14F21L0212), (01)10801902132922 (17)231130 (10)14F21L0218 (14F21L0218), (01)10801902196375 (17)231231 (10)14F21M0101 (14F21M0101), (01)10801902196375 (17)231231 (10)14F22A0055 (14F22A0055), (01)10801902196375 (17)240229 (10)14F22C0101 (14F22C0101), (01)10801902196375 (17)240430 (10)14F22E0008 (14F22E0008), (01)10801902196375 (17)240531 (10)14F22F0152 (14F22F0152), (01)10801902196375 (17)240731 (10)14F22G0219 (14F22G0219), (01)10801902196375 (17)240731 (10)14F22G0243 (14F22G0243), (01)10801902196375 (17)240831 (10)14F22J0148 (14F22J0148), (01)10801902196375 (17)241031 (10)14F22K0211 (14F22K0211), (01)10801902196375 (17)241130 (10)14F22M0119 (14F22M0119), (01)10801902196375 (17)241231 (10)14F23A0072 (14F23A0072); j. Product Code: EDC-00622-B. UDI (Batch Number): (01)10801902133028 (17)230831 (10)13F21J0635 (13F21J0635), (01)10801902133028 (17)240430 (10)13F22E0264 (13F22E0264), (01)10801902133028 (17)240831 (11)220928 (10)13F22J0565 (13F22J0565), (01)10801902133028 (17)241031 (11)221103 (10)13F22K1119 (13F22K1119), (01)10801902133028 (17)241130 (11)221214 (10)13F22M0124 (13F22M0124), (01)10801902133028 (17)241130 (11)230102 (10)13F22M0459 (13F22M0459); k. Product Code: EDC-00818. UDI (Batch Number): (01)10801902132946 (17)230531 (10)14F21F0077 (14F21F0077), (01)10801902132946 (17)230731 (10)14F21G0241 (14F21G0241), (01)10801902132946 (17)230731 (10)14F21H0187 (14F21H0187), (01)10801902132946 (17)230831 (10)14F21H0219 (14F21H0219), (01)10801902132946 (17)230831 (10)14F21J0110 (14F21J0110), (01)10801902132946 (17)231031 (10)14F21J0170 (14F21J0170), (01)10801902132946 (17)230930 (10)14F21K0054 (14F21K0054), (01)10801902132946 (17)231130 (10)14F21L0213 (14F21L0213), (01)10801902132946 (17)231130 (10)14F21L0214 (14F21L0214), (01)10801902132946 (17)231130 (10)14F21L0219 (14F21L0219), (01)10801902196382 (17)231231 (10)14F22A0189 (14F22A0189), (01)10801902196382 (17)231231 (10)14F22A0190 (14F22A0190), (01)10801902196382 (17)240229 (10)14F22C0102 (14F22C0102), (01)10801902196382 (17)240229 (10)14F22C0103 (14F22C0103), (01)10801902196382 (17)240229 (10)14F22C0104 (14F22C0104), (01)10801902196382 (17)240331 (10)14F22D0101 (14F22D0101), (01)10801902196382 (17)240430 (10)14F22E0010 (14F22E0010), (01)10801902132946 (17)240531 (10)14F22F0005 (14F22F0005), (01)10801902196382 (17)240531 (10)14F22F0006 (14F22F0006), (01)10801902196382 (17)240531 (10)14F22F0089 (14F22F0089), (01)10801902196382 (17)240630 (10)14F22G0123 (14F22G0123), (01)10801902196382 (17)240831 (10)14F22H0344 (14F22H0344), (01)10801902196382 (17)240831 (10)14F22J0208 (14F22J0208), (01)10801902196382 (17)240930 (10)14F22K0128 (14F22K0128), (01)10801902196382 (17)240930 (10)14F22K0129 (14F22K0129), (01)10801902196382 (17)241031 (10)14F22K0212 (14F22K0212), (01)10801902196382 (17)241031 (10)14F22K0213 (14F22K0213), (01)10801902196382 (17)241231 (10)14F23A0180 (14F23A0180), (01)10801902196382 (17)241231 (10)14F23A0309 (14F23A0309), (01)10801902196382 (17)250228 (10)14F23B0330 (14F23B0330); l. Product Code: EDC-00818-B. UDI (Batch Number): (01)10801902133042 (17)230531 (10)13F21F1022 (13F21F1022), (01)10801902133042 (17)230831 (10)13F21J0283 (13F21J0283), (01)10801902133042 (17)230930 (10)13F21K0047 (13F21K0047), (01)10801902133042 (17)231031 (10)13F21L0563 (13F21L0653), (01)10801902133042 (17)231231 (10)13F21M0598 (13F21M0598), (01)10801902133042 (17)240229 (10)13F22C0492 (13F22C0492), (01)10801902133042 (17)240430 (10)13F22E0440 (13F22E0440), (01)10801902133042 (17)240831 (11)220923 (10)13F22J0572 (13F22J0572), (01)10801902133042 (17)240930 (11)221021 (10)13F22K0681 (13F22K0681), (01)10801902133042 (17)241031 (11)221114 (10)13F22L0279 (13F22L0279), (01)10801902133042 (17)241130 (11)221213 (10)13F22M0125 (13F22M0125), (01)10801902133042 (17)250228 (11)230309 (10)33F23B1023 (33F23B1023); m. Product Code: EDC-00820. UDI (Batch Number): (01)10801902132960 (17)230831 (10)14F18H0447 (14F18H0447), (01)10801902132960 (17)230531 (10)14F21E0293 (14F21E0293), (01)10801902132960 (17)230531 (10)14F21F0076 (14F21F0076), (01)10801902132960 (17)230731 (10)14F21F0253 (14F21F0253), (01)10801902132960 (17)230731 (10)14F21G0239 (14F21G0239), (01)10801902132960 (17)231031 (10)14F21J0114 (14F21J0114), (01)10801902132960 (17)230930 (10)14F21J0372 (14F21J0372), (01)10801902132960 (17)230930 (10)14F21K0052 (14F21K0052), (01)10801902132960 (17)231031 (10)14F21L0138 (14F21L0138), (01)10801902132960 (17)231031 (10)14F21L0139 (14F21L0139), (01)10801902132960 (17)231130 (10)14F21L0215 (14F21L0215), (01)10801902132960 (17)231130 (10)14F21L0216 (14F21L0216), (01)10801902132960 (17)231130 (10)14F21L0220 (14F21L0220), (01)10801902132960 (17)231130 (10)14F21M0014 (14F21M0014), (01)10801902196399 (17)240229 (10)14F22C0105 (14F22C0105), (01)10801902196399 (17)240229 (10)14F22C0106 (14F22C0106), (01)10801902196399 (17)240229 (10)14F22C0107 (14F22C0107), (01)10801902196399 (17)240229 (10)14F22C0108 (14F22C0108), (01)10801902196399 (17)240229 (10)14F22C0109 (14F22C0109), (01)10801902196399 (17)240229 (10)14F22C0110 (14F22C0110), (01)10801902196399 (17)240331 (10)14F22D0085 (14F22D0085), (01)10801902196399 (17)240331 (10)14F22D0086 (14F22D0086), (01)10801902196399 (17)240331 (10)14F22D0087 (14F22D0087), (01)10801902196399 (17)240430 (10)14F22E0114 (14F22E0114), (01)10801902196399 (17)240430 (10)14F22E0117 (14F22E0117), (01)10801902132960 (17)240531 (10)14F22F0008 (14F22F0008), (01)10801902196399 (17)240531 (10)14F22F0090 (14F22F0090), (01)10801902196399 (17)240630 (10)14F22G0124 (14F22G0124), (01)10801902196399 (17)240630 (10)14F22G0125 (14F22G0125), (01)10801902196399 (17)240831 (10)14F22H0345 (14F22H0345), (01)10801902196399 (17)240930 (10)14F22K0030 (14F22K0030), (01)10801902196399 (17)240930 (10)14F22K0159 (14F22K0159), (01)10801902196399 (17)241031 (10)14F22K0222 (14F22K0222), (01)10801902196399 (17)241031 (10)14F22L0072 (14F22L0072), (01)10801902196399 (17)241130 (10)14F22M0039 (14F22M0039), (01)10801902196399 (17)241130 (10)14F22M0040 (14F22M0040), (01)10801902196399 (17)241130 (10)14F22M0117 (14F22M0117), (01)10801902196399 (17)241130 (10)14F22M0118 (14F22M0118), (01)10801902196399 (17)241231 (10)14F23A0178 (14F23A0178), (01)10801902196399 (17)241231 (10)14F23A0310 (14F23A0310), (01)10801902196399 (17)241231 (10)14F23A0311 (14F23A0311), (01)10801902196399 (17)250228 (10)14F23B0326 (14F23B0326), (01)10801902196399 (17)250228 (10)14F23B0327 (14F23B0327); n. Product Code: EDC-00820-B. UDI (Batch Number): (01)10801902133066 (17)230531 (10)13F21E0851 (13F21E0851), (01)10801902133066 (17)230531 (10)13F21F0214 (13F21F0214), (01)10801902133066 (17)230531 (10)13F21F0524 (13F21F0524), (01)10801902133066 (17)230531 (10)13F21F1021 (13F21F1021), (01)10801902133066 (17)230630 (10)13F21G1201 (13F21G1201), (01)10801902133066 (17)230731 (10)13F21H0533 (13F21H0533), (01)10801902133066 (17)230731 (10)13F21H0824 (13F21H0824), (01)10801902133066 (17)230831 (10)13F21J0067 (13F21J0067), (01)10801902133066 (17)230831 (10)13F21J0597 (13F21J0597), (01)10801902133066 (17)230930 (10)13F21K0048 (13F21K0048), (01)10801902133066 (17)231031 (10)13F21L0427 (13F21L0427), (01)10801902133066 (17)231130 (10)13F21M0283 (13F21M0283), (01)10801902133066 (17)240131 (10)13F22A1064 (13F22A1064), (01)10801902133066 (17)240430 (10)13F22E0183 (13F22E0183), (01)10801902133066 (17)240630 (11)220718 (10)13F22G0461 (13F22G0461), (01)10801902133028 (17)241130 (11)230102 (10)13F22M0459 (13F22J0599), (01)10801902133066 (17)240930 (11)221028 (10)13F22K1046 (13F22K1046), (01)10801902133066 (17)241031 (11)22115 (10)13R22J0599 (13R22J0599), (01)10801902133066 (17)250228 (11)230308 (10)33F23B1066 (33F23B1066), (01)10801902133066 (17)250228 (11)230328 (10)33F23C0237 (33F23C0237), (01)10801902133066 (17)250331 (11)230404 (10)33F23C0974 (33F23C0974); o. Product Code: EDC-00822. UDI (Batch Number): (01)10801902132984 (17)230731 (10)14F21G0118 (14F21G0118), (01)10801902132984 (17)230731 (10)14F21H0188 (14F21H0188), (01)10801902132984 (17)231130 (10)14F21L0217 (14F21L0217), (01)10801902196405 (17)240331 (10)14F22D0102 (14F22D0102), (01)10801902196405 (17)241231 (10)14F23A0063 (14F23A0063), (01)10801902196405 (17)250131 (10)14F23B0128 (14F23B0128); p. Product Code: EDC-00822-B. UDI (Batch Number): (01)10801902133080 (17)230930 (10)13F21K0049 (13F21K0049), (01)10801902133080 (17)231031 (10)13F21L0020 (13F21L0020), (01)10801902133080 (17)240430 (10)13F22E0443 (13F22E0443), (01)10801902133080 (17)240831 (11)220924 (10)13F22J0463 (13F22J0463), (01)10801902133080 (17)240930 (11)221021 (10)13F22K0572 (13F22K0572), (01)10801902133080 (17)241031 (11)221115 (10)13F22L0388 (13F22L0388), (01)10801902133080 (17)240831 (11)220922 (10)13R22H0448 (13R22H0448)
• Recalling Firm/ Manufacturer: ARROW INTERNATIONAL Inc.; 3015 Carrington Mill Blvd; Morrisville NC 27560-5437
• For Additional Information Contact: Teleflex Customer Service; 866-396-2111
• Manufacturer Reason for Recall: Potential for catheter separation or leakage
• FDA Determined Cause: Under Investigation by firm
• Action: Arrow International/Teleflex sent customers an "URGENT MEDICAL DEVICE RECALL" letter, via FedEx, on 05/19/2023. Customers were instructed to check for affected products in inventory, immediately discontinue use and quarantine the products and complete and return the Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. Should you require further information or support concerning this issue, please contact Customer Service via email, phone, or FAX using the details provided below. Customer Service hours of operation are 8am 7pm EST. Contact: Customer Service Telephone: 1-866-396-2111 FAX: 1-855-419-8507 Email: Recalls@teleflex.com If you have any questions, please contact your local Teleflex sales representative or Teleflex Customer Service.
• Quantity in Commerce: 262,016 units
• Distribution: Nationwide distribution. International distribution to Canada.
• Total Product Life Cycle: TPLC Device Report

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.

• 510(K) Database: 510(K)s with Product Code = FOZ and Original Applicant = Arrow International, Inc. (subsidiary of Teleflex Inc.)