McGaw Stratus Infusion pumps 28 units. Class II

McGaw Stratus Ambulatory Infusion System Model 550 and Alphamed EZ Pump, Model 550 withSoftware Version 2.32.00/2.42.01. Recall #Z-188-9.

REASON

The pump could under infuse or blood could back up into IV lines when the pumps are running at a slow
flow rate with a large infusion set.

CODE

Serial Numbers: P61145, P71108, P71115, P71125, P71130, P71135, P71142, P71147, P71152, P71157,
P71162, P71166, P71167, P71168, P71173, P71183, P71185, P71192, P71194, P71195, P71201,
P71202, P71205, P71208, P71210, P71211, P71216, P71225, P71233, P71234, P71243, P71244,
P71259, P71266, P71283, P71319, P71607, P71616, P71620, P71621, P71626, P71647, P71649,
P71652.

MANUFACTURER

Alphamed, Inc., Norcross, Georgia.

RECALLED BY

Manufacturer, by returning product around June 1997. Firm-initiated recall complete.

DISTRIBUTION

Texas.

QUANTITY

28 pumps with software version 2.32.00/2.42.01 were distributed.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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