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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Latex Free CSection CDSLF and CSection Supplemental CDSLF

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  Class 2 Device Recall Medline Latex Free CSection CDSLF and CSection Supplemental CDSLF see related information
Date Initiated by Firm August 04, 2008
Date Posted October 10, 2008
Recall Status1 Terminated 3 on October 20, 2008
Recall Number Z-0015-2009
Recall Event ID 49107
Product Classification Cesarean Section Kit - Product Code OHM
Product Medline Latex Free C-Section CDS-LF and C-Section Supplemental 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 C-SECTION CDS-LF reorder # CDS820056A, lot 05BD1698;  reorder #CDS820056C, lots 05IB0778, 05JB0082, 05KB0104, 06AB1030, 06AB2380, 06CB1531, 06EB0704, 06FB1115, 06GB1927, 06HB1461, 06HB2418, 06HB2777, 06IB0097, 06IB2563, 06JB0041, 06KB2184, 07AB2727, 07AB3311, 07BB1516, 07CB1820, 07EB0471; reorder #CDS820118B, lots 06KG0719, 06KG1087, 07AG0244, 07DG0851, 07FG1471, 07IG0560, 07JG0122, 08BG1227, 06DD3830, 06ED3336, 06FD4857, 06HD0004; reorder #CDS820118C, lots 08CG1139, 08EG1366;   C-SECTION SUPPLEMENTAL CDS-LF reorder #CDS820024F, lots 06KD0503, 06LD0368, 07CD2689, 07ED4161, 07ID0877, 07JD3499;  reorder #CDS820024G, lots 08BD3947, 08ED3486;  
Recalling Firm/
Manufacturer		 Medline Industries Inc
1 Medline Pl
Mundelein IL 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		 Employee error
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 579 cases
Distribution Nationwide Distribution --- including states of Alabama, Arizona, Georgia, Missouri, Nevada, New Jersey, and Washington.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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