FDA Medical Device Recalls (openFDA)
Medline Industries Inc: 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 number
- Z-0018-2009
- Recalling firm
- Medline Industries Inc
- Product
- 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
- Status
- Terminated
- Initiated
- 2008-08-04
- Posted
- 2008-10-10
- Terminated
- 2008-10-20
- 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.
- 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
- 497 cases
- Distribution
- Nationwide Distribution --- including states of Alabama, Arizona, Georgia, Missouri, Nevada, New Jersey, and Washington.
- Lot, serial or model codes
- LABOR & DELIVERY CDS-LF reorder #CDS830142, lot 05CD1070; reorder # CDS830142A, lots 05ED0630, 05ED3423, 05FD4160; reorder #CDS830142C, lot 05ID2386; reorder # CDS830142D, lots 05KD3498, 05LD0193, 05LD1753, 06AD3708;
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OHM
- Firm FEI
- 1417592
- Firm city
- Mundelein
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28