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Terminated

Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path

FDA Recall Z-0194-2016 · Posted None

Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeKDJ
Date Initiated2015-10-06
Date Terminated2016-06-27
Product Quantity19,440 units

Reason for Recall

Leakage from the inlet port of the 15L Cycler Drainage Bags.

Firm Action

Baxter sent an Urgent Product Recall letter dated October 8, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recalling firm will ask customers to locate and separate all affected products, contact the recalling firm to arrange for a return, and complete the customer reply form. Further questions, please call (800) 422-9837.

Root Cause

Under Investigation by firm

Distribution Pattern

US Distribution and Internationally to Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K791899CYCLER SETS MOD. #5C4143, 5C4144, 5C4145Travenol Laboratories, S.A. · 1979-11-13

Official Source

View FDA Recall →

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

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