Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1770-2019 — Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 10013361T, 2110-0500, 2126-0500, 2200-0500, 2411-0500, 2419-0007, 2420-0007, 2420-0500, 2421-0500, 2426-0007, 2426-0500, 2429-0500, 2433-0007, 2477-0000, 2477-000

U.S. FDA — Device Enforcement · United States · 2019-05-06 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1770-2019
Date of alert
2019-05-06
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Becton Dickinson & Company
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07613203021135
Reported risk: An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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