Medline Industries, Inc.

Entity profile compiled from public source records

Public Record Profile Registrations: 0 510(k) filings: 3 Recalls: 7

Known Identifiers & Locations

FEI Numbers 1417592
Owner Operator Numbers N/A
Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (3)

Submission # Device Name Decision Date Decision Description Action
K210526 Medline Cautery Tip Cleaner 2021-03-12 Substantially Equivalent View Details
K772144 CATHETER, DISP., EXTERNAL, MALE 1977-11-28 Substantially Equivalent View Details
K791969 DYNACOR STERILE CLOSED SYS. DRAINAGE BAG 1979-11-05 Substantially Equivalent View Details

FDA Recall History (7)

Recall # Product Description Initiation Date Status Action
Z-0015-2009 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 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. 2008-08-04 Terminated View Details
Z-0016-2009 Medline Latex Free Vaginal 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 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. 2008-08-04 Terminated View Details
Z-0017-2009 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 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. 2008-08-04 Terminated View Details
Z-0018-2009 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 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. 2008-08-04 Terminated View Details
Z-0019-2009 Medline Latex Free Mom/Baby Admit Kit - LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060 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. 2008-08-04 Terminated View Details
Z-0036-2007 Medline Strider Maxi 3 Scooter; a three wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mundelein, IL 60060 USA; model MDS807600 - red and MDS807600B - blue Reason: Under conditions of heavy use, signs of overheating of the main battery cables have been observed. 2006-07-20 Terminated View Details
Z-0037-2007 Medline Strider Maxi 4 Scooter; a four wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mundelein, IL 60060 USA; model MDS807650 - red and MDS807650B - blue Reason: Under conditions of heavy use, signs of overheating of the main battery cables have been observed. 2006-07-20 Terminated View Details

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