ARROW INTERNATIONAL Inc.: ARROW Endurance Extended Dwell Peripheral Catheter System

Hazard

Potential for catheter separation or leakage

Details from the source

Reason for recall: Potential for catheter separation or leakage Distribution: Nationwide distribution. International distribution to Canada. Quantity: 262,016 units Lot/code info: 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), (0

UPC codes

10801902212105, 10801902193022, 10801902212112, 10801902144499, 10801902146318, 10801902192988, 10801902132908, 10801902196368, 10801902133004, 10801902132922, 10801902196375, 10801902133028, 10801902132946, 10801902196382, 10801902133042, 10801902132960, 10801902196399, 10801902133066, 10801902132984, 10801902196405, 10801902133080

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.