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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Latex Free Labor Kit & Postpartum CDSLF

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 Class 2 Recall
Medline Latex Free Labor Kit & Postpartum CDSLF
see related information
Date Posted October 10, 2008
Recall Status1 Terminated on February 02, 2010
Recall Number Z-0017-2008
Recall Event ID 49107
Premarket Approval
PMA Number
P040033
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
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
Code Information 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;
Recalling Firm/
Manufacturer
Medline Industries Inc
1 Medline Pl
Mundelein, Illinois 60060-4486
For Additional Information Contact Ms. Kathy Dunne
866-359-1704
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
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.
Quantity in Commerce 279 cases
Distribution Nationwide Distribution --- including states of Alabama, Arizona, Georgia, Missouri, Nevada, New Jersey, and Washington.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LXH and Applicant = SMITH & NEPHEW, INC.
PMAs with Product Code = LXH and Applicant = SMITH&NEPHEW ORTHOPAEDICS
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