FDA Recall Terminated

Medline Latex Free Labor & Delivery CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060

Recall: Z-0018-2009 · Initiated August 4, 2008

Recall

Recall Number: Z-0018-2009
Event Number: 49107
Firm: Medline Industries Inc
FEI Number: 1417592
Product Code: OHM
Status: Terminated
Root Cause: Employee error
Initiated: August 4, 2008
Posted: October 10, 2008
Terminated: October 20, 2008
Address: 1 Medline Pl, Mundelein, IL, 60060-4486

Description

Reason

The latex free labor & delivery packs contain a latex Nuk pacifier. The pacifier is packaged separately and offers no risk of exposure of latex particles to other components of the pack.

Action

Recall letters dated 8/4/08 were sent to the direct accounts on the same date, informing them that the labor and delivery packs were labeled Latex Free, but contained a Latex Nuk pacifier. The letters were customized for each account, listing the specific affected reorder numbers and lot numbers shipped to each account. The accounts were requested to immediately check their stocks for the affected lot numbers and quarantine the affected product found. The accounts were given three options: A) Attach the enclosed stickers to the packs so that the user is aware of the latex Nuk pacifier, B) Call Medline to receive replacement non-latex pacifiers, but also place the stickers on the packs, C) Return the packs to Medline for replacements. The accounts were requested to complete the enclosed response form, indicating which option the account selected and whether they needed any additional stickers, and fax the form back to Medline at 847-643-4482 by 8/18/08. Any questions were directed to Kathy Dunne at 1-866-359-1704.

Distribution

Nationwide Distribution --- including states of Alabama, Arizona, Georgia, Missouri, Nevada, New Jersey, and Washington.

Quantity

497 cases