Baxter Single Day Infusor 2 mL/h Portable Elastomeric Infusion System; an Rx sterile disposable drug delivery system; Ba

FDA device recall Z-2146-2011 · posted 2011-05-05 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

Some of the Single Day Infusor System 2 mL/h have a foil over-pouch that was incorrectly labeled as the Half Day Infusor System 5 mL/h, product code 2C1073KJP, lot 10H054.

Action taken

Baxter Healthcare Corp. sent Urgent Product Recall letters dated March 15, 2011, via first class mail to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The accounts were requested to examine all of their inventory locations for both product code 2C1071KJP and 2C1073KJP, lot 10H054, and return the affected lot for replacement or credit. The accounts were also requested to complete the attached customer reply form listing the number of held for return, and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to Baxter's Center for One Baxter at 1-800-422-9837.

Root cause

Labeling mix-ups

Status

Terminated

Product code

MEB

Quantity affected

3,696 units

Distribution

Worldwide Distribution - USA including AL and the countries of Mexico and Spain

Date initiated

2011-03-15

Date posted

2011-05-05

Date terminated

2012-03-12

Location

Round Lake, IL

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