Device recall enforcement reports

MEDLINE medical convenience kits labeled as: C-SECTION TRAY-LF, Medline Kit Number/SKU OBN471K

Medline Industries, LP · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

Class IIOngoingZ-0280-2027
Status
Ongoing
City
Northfield
State
IL
Country
United States
Classification
Class II
Product type
Devices
Event ID
99960
Recalling firm
Medline Industries, LP
Address 1
3 Lakes Dr
Postal code
60093-2753
Voluntary mandated
Voluntary: Firm initiated
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution pattern
Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.
Recall number
Z-0280-2027
Product description
MEDLINE medical convenience kits labeled as: C-SECTION TRAY-LF, Medline Kit Number/SKU OBN471K
Product quantity
108 kits
Reason for recall
Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
Recall initiation date
20260909
Center classification date
20261022
Report date
20261028
Code info
UDI/DI 10889942132669 (each) 40889942132660 (case), Lot numbers: 26BBR121, 25LBL570, 25JBN486.
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.