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Terminated

Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.

FDA Recall Z-1945-2014 · Posted 2014-06-30

Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeKDI
Date Initiated2013-07-08
Date Terminated2014-06-30
Product Quantity20,940 units

Reason for Recall

the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil layer. The upper paper layer may serve as a protective barrier and help support overall packaging.

Firm Action

An Urgent Product Recall notification was mailed via U.S.P.S. first-class mail to facilities, (dialysis centers and distributors) on July 8, 2013 and mailed by first-class mail to home patients on July 11, 2013.

Root Cause

Packaging change control

Distribution Pattern

Distributed in the states of AR, TN MO, KS, TX, MS, and AL.

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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