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Terminated

Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Intended to isolate the Easy-Lock connector of the solution transfer set.

FDA Recall Z-1565-2013 · Posted 2013-06-21

Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeKDI
Date Initiated2013-05-21
Date Terminated2016-07-14
Product Quantity629,280 units

Reason for Recall

leaking pouches

Firm Action

The firm, Baxter Healthcare Corporation sent an "URGENT PRODUCT RECALL" letter dated May 21, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For general questions regarding this communication, contact The Center for One Baxter at 1-800-422-9837.

Root Cause

Packaging change control

Distribution Pattern

Nationwide Distribution.

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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