Z-0015-2009

Medline Latex Free C-Section CDS-LF and C-Section Supplemental CDS-LF; a single patient prescription...

Name: Z-0015-2009 Medline Latex Free C-Section CDS-LF and C-Section Supplemental CDS-LF; a single patient prescription...
Creator: Medline Industries Inc
Published: 2008-08-04
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2008-08-04 / Terminated / root cause: manufacturing process

FDA source

Medline Industries Inc began a recall of 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... on 2008-08-04. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0015-2009
Status: Terminated
Initiated: 2008-08-04
Posted: 2008-10-10
Terminated: 2008-10-20
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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
Product code: OHM Cesarean Section Tray
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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;

Product code OHM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)