—#73461

Product

Medline Latex Free Labor Kit & Postpartum 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

FDA product code: OHM — Cesarean Section Tray
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
Affected lot / code info: LABOR KIT & POSTPARTUM CDS-LF reorder # CDS830074D, lots 05HB0427, 05IB0654, 05IB1857, 05KB0229, 06AB1244, 06BB0159, 06CB0593, 06CB1926, 06CB2197, 06FB0015, 06FB0476, 06GB0916, 06HB0704, 06HB2791, 06IB1312, 06IB1922, 06IB2566, 06KB0020, 06KB1042, 06KB2322, 06LB2102, 07AB0437, 07BB2798, 05AD3274, 05BD4131, 05CD3200, 05FD2631; reorder #CDS830074F, lots 07DB1578, 07GB1509, 07IB0792, 07JB0627, 07JB1829, 07LB0150, 07LB0508, 08BB0151;

Why it was recalled

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.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: 1 Medline Pl, Mundelein, Illinois 60060-4486

Distribution

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

Timeline

Recall initiated: 2008-08-04
Posted by FDA: 2008-10-10
Terminated: 2008-10-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73461. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.