FDA Device Recall Z-0019-2009: Medline Industries Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0019-2009.

Recall Res Number

Z-0019-2009

Recalling Firm / Manufacturer

Medline Industries Inc

FEI Number

1417592

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2008-08-04

Date Posted

2008-10-10

Date Terminated

2008-10-20

Product Code

OHM

Event Number

49107

Product Quantity

514 cases

Product Description 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 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.

Action Details 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.

Distribution Pattern Nationwide Distribution --- including states of Alabama, Arizona, Georgia, Missouri, Nevada, New Jersey, and Washington.

Code Information / Serial Numbers MOM/BABY ADMIT KIT-LF reorder #CDS981005, lots 07KB4947, 07LB1748, 08CB4728; reorder #CDS981005A, lots 08EB1474, 08FB3264, 08FB3383;

Related Establishments / Registrations

Sterigenics U.S., LLC Registration: 1018470 View Registration
MEDICAL ACTION INDUSTRIES, INC. 306 Registration: 1030451 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1043214 View Registration
AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY 305 Registration: 1047429 View Registration
DeRoyal Industries, Inc. Registration: 1054241 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1055236 View Registration
Sterigenics U.S., LLC Registration: 1061124 View Registration
MEDLINE INDUSTRIES, LP - Northfield Registration: 1417592 View Registration
MEDLINE INDUSTRIES, LP - SPT Registration: 1423395 View Registration
Cardinal Health 200, LLC Registration: 1423537 View Registration
ISOMEDIX OPERATIONS INC Registration: 1643817 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
Sterigenics U.S., LLC Registration: 2029015 View Registration
BUSSE HOSPITAL DISPOSABLES Registration: 2433012 View Registration
Sterigenics US LLC Registration: 3004111573 View Registration
PRODUCTOS MEDLINE S.A. DE C.V. Registration: 3004122598 View Registration
Sino Protection (Hefei) Medical Products Co. ltd. Registration: 3004362278 View Registration
GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD. Registration: 3004911384 View Registration
MIDWEST STERILIZATION CORP. Registration: 3005012805 View Registration
MEDLINE INDUSTRIES, LP - Laredo Registration: 3005595283 View Registration
Cardinal Health 200, LLC Registration: 3007329020 View Registration
PACKROOM LLC Registration: 3008513424 View Registration
GRI-Alleset, Inc. Registration: 3009203853 View Registration
Isomedix Operations Inc Registration: 3009888344 View Registration
Medline Industries, LP - Mexicali (MXC) Registration: 3015173212 View Registration
ADVANCED PRODUCT SOLUTIONS INC. Registration: 3018071447 View Registration
INVENIO ALTERNATE CARE SOLUTIONS, LLC Registration: 3026197444 View Registration
Honduras Kitting, S.A. Registration: 3035642068 View Registration
Convertors de Mexico S. de R.L. de C.V Registration: 9616088 View Registration

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Medical Device Recall: Z-0019-2009

Recall Parameters & Description

Related Establishments / Registrations

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