ARROW recallZ-1826-2023 · ARROW INTERNATIONAL Inc. · initiated May 19, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ARROW INTERNATIONAL Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for catheter separation or leakage
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1826-2023
- Status
- Open, Classified
- Initiated by the company
- May 19, 2023
- Posted by the FDA
- Jun 21, 2023
- Recalling firm
- ARROW INTERNATIONAL Inc.
- Quantity
- 262,016 units
- Product code
- FOZ
- FDA submissions
- K163513
- Distribution
- Nationwide distribution. International distribution to Canada.
Product description
ARROW Endurance Extended Dwell Peripheral Catheter System
Code information (models, lots, serial numbers)
Show the full code information (16k characters)
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)
Devices named in this recall
21 devices in the FDA device registry whose identifier appears in the recall's code information.
- ARROW IPN037859Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall4 reports
- ARROW IPN037862Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall2 reports
- ARROW IPN037864Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall2 reports
- ARROW IPN037867Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall2 reports
- ARROW IPN920647Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall2 reports
- ARROW IPN037860Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall1 report
- ARROW IPN920649Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall1 report
- ARROW IPN037861Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- ARROW IPN037863Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- ARROW IPN037865Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- ARROW IPN037866Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- ARROW IPN037868Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- ARROW IPN029787Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPN055182Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPN920320Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPN920321Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPN920648Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPN920650Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPN920651Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPN926624Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPN926640Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K163513 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ARROW IPN037845Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- ARROW IPN037847Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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