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Terminated

Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.

FDA Recall Z-2074-2014 · Posted 2014-07-17

Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeKDI
Date Initiated2014-06-17
Date Terminated2015-04-03
Product Quantity585,360 units

Reason for Recall

Inadequate iodine and packaging related defects.

Firm Action

The firm notified their direct consignees on 06/17/2014 by letter requesting customers to locate and remove all affected product from their facility, and contact Baxter Healthcare Center for Service to arrange for return and credit.

Root Cause

Packaging process control

Distribution Pattern

Distributed USA (nationwide) and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K895631DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466Baxter Healthcare Corp · 1990-01-29

Official Source

View FDA Recall →

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

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