Z-1826-2023Class I
ARROW Endurance Extended Dwell Peripheral Catheter System
Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2023-05-19 / Open, Classified
ARROW INTERNATIONAL Inc. began a recall of ARROW Endurance Extended Dwell Peripheral Catheter System on . FDA classified it as Class I and gives the reason as "Potential for catheter separation or leakage". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-1826-2023
- Classification
- Class I
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Arrow International LLC (subsidiary of Teleflex Incorporated)
- Product
- ARROW Endurance Extended Dwell Peripheral Catheter System
- Product code
- FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Reason for recall
- Potential for catheter separation or leakage
- FDA root 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 [email protected]. 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: [email protected] 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.
- Product codes and lots
- 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)
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1826-2023 | Class I | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.