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Terminated

MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484

FDA Recall Z-0831-2022 · Posted None

Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeKDJ
Date Initiated2022-02-25
Date Terminated2026-05-15
Product Quantity498 units

Reason for Recall

Devices distributed lacked regulatory clearance.

Firm Action

An Urgent Medical Device Recall communication was sent to affected customers via U.S.P.S., first class mail on 02/25/2022. Instructions within the communication request customers to locate and return any unused affected product codes and lots from their facility, contact Baxter Healthcare Center for Service to arrange for return and credit at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday, and acknowledge the receipt of this notification by completing a reply form on the customer portal.

Root Cause

No Marketing Application

Distribution Pattern

US Nationwide distribution in the states of California, Colorado, District of Columbia, Delaware, Florida, Georgia, Illinois, Louisiana, Michigan, Missouri, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, and Texas.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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