The Recall Desk
SevereFDA (Devices)·Z-1826-2023·Announced 2023-06-28

ARROW Endurance Peripheral Catheters Recalled for Separation and Leakage Risk

ARROW Endurance Extended Dwell Peripheral Catheters are being recalled due to potential catheter separation or leakage. The recall affects 262,016 units distributed nationwide and in Canada.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification requires a minimum severity score of 4. The potential for catheter separation or leakage during use poses a serious risk to patient safety, though no specific injuries or deaths are reported in the source.

Plain-English summary

ARROW Endurance Extended Dwell Peripheral Catheter System is a medical device used for vascular access. The recall affects 262,016 units of various product codes and batch numbers.

The FDA classified this as a Class I recall due to potential for catheter separation or leakage during use. This potential malfunction poses a risk to patient safety.

The affected products were distributed nationwide in the United States and to Canada through multiple product codes and batch numbers.

Healthcare facilities using these catheters should identify any units from the recalled batch numbers and quarantine them immediately. Any units in use should be removed and replaced with devices from non-recalled batches. Facility staff should verify their inventory against the specific product codes and batch numbers provided in this recall notice.

The recalled product

Product
ARROW Endurance Extended Dwell Peripheral Catheter System
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Vascular Access / Catheters
Hazard
  • catheter-separation
  • leakage

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • (01)10801902212105 (17)240630 (11)221118 (10)13F22L0492 (13F22L0492)
  • (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)
  • (01)10801902212112 (17)240630 (11)221114 (10)13F22L0361 (13F22L0361)
  • (01)10801902144499 (17)240229 (11)220324 (10)13F22C0480 (13F22C0480)
  • (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)
  • (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)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category