15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.

FDA device recall Z-0080-2015 · posted 2014-10-17 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp

Reason for recall

The large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully close the drain tube and may result in leakage.

Action taken

Baxter sent an Urgent Product Recall letter dated May 30, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. The recalling firm is instructing their customers to remove all affected products from their facility and quarantine the product subject to the recall. Customers are instructed to return the affected product to Baxter and receive a credit or replacement. For questions contact the Center for One Baxter at 1-800-422-9837.

Root cause

Component change control

Status

Terminated

Product code

KDJ

Quantity affected

3,085,080

Distribution

Worldwide Distribution - US Nationwide (including Puerto Rico) and countries of, Canada, Australia, New Zealand, Thailand, Malaysia, Singapore, Korea, Japan, Philippines, Columbia, Ecuador, Austria, B

Date initiated

2013-10-17

Date posted

2014-10-17

Date terminated

2016-01-04

Location

Deerfield, IL

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