Recall Z-1770-2019— Becton Dickinson & Company

Name: FDA recall Z-1770-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-06

Class I · Terminated

Class I FDA medical device recall by Becton Dickinson & Company, initiated 2019-05-06, terminated 2021-07-19. It names one FDA 510(k) clearance: K894842. Product: 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, 2477-0007 2478-0000 C24116E Infusion sets allow for the intravenous administration of fluids, medications, nutritional support and transfusion therapy through a needle or catheter inserted into the patient s artery or vein.. Reason: 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..

Recalling firm: Becton Dickinson & Company
Classification: Class I
Status: Terminated
Initiated: 2019-05-06
Terminated: 2021-07-19
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K894842 — IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADMImed Corp.·cleared 1989-09-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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, 2477-0007 2478-0000 C24116E Infusion sets allow for the intravenous administration of fluids, medications, nutritional support and transfusion therapy through a needle or catheter inserted into the patient s artery or vein.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.