Recall archive
9 recalls · page 1 of 1
Reported Oct 2, 2024
Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ARROW INTERNATIONAL Inc.
Matched: Brand · Product · Product details — Reports have been received regarding open seals on the packaging.
FDA (openFDA device enforcement)
Reported Jun 12, 2024
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
High riskUsing this product could cause serious injury, illness or death — stop using it now.ARROW INTERNATIONAL Inc.
Matched: Brand · Product · Product details — Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 27, 2024
ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ARROW INTERNATIONAL Inc.
Matched: Brand · Product · Product details — Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component.…
FDA (openFDA device enforcement)
Reported Oct 11, 2023
Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ARROW INTERNATIONAL Inc.
Matched: Brand · Product · Product details — This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 27, 2023
Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ARROW INTERNATIONAL Inc.
Matched: Brand · Product · Product details — This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 28, 2023
ARROW Endurance Extended Dwell Peripheral Catheter System
High riskUsing this product could cause serious injury, illness or death — stop using it now.ARROW INTERNATIONAL Inc.
Matched: Brand · Product · Product details — Potential for catheter separation or leakage
FDA (openFDA device enforcement)
Reported Dec 21, 2022
Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer
High riskUsing this product could cause serious injury, illness or death — stop using it now.ARROW INTERNATIONAL Inc.
Matched: Brand · Product · Product details · Reason for recall — There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC…
32 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 26, 2022
ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ARROW INTERNATIONAL Inc.
Matched: Brand · Product · Product details — Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5…
FDA (openFDA device enforcement)
Reported Jul 6, 2022
Arrow Three-Lumen CVC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ARROW INTERNATIONAL Inc.
Matched: Brand · Product · Product details — Gravity flow rates on the affected product lidstock are incorrect.
FDA (openFDA device enforcement)
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