Z-1435-2024 Class II Ongoing
FDA device recall Z-1435-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Feb 23, 2024 and is designated Class II. Reason for recall: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. The recall status is ongoing. Affected quantity: 1520 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 10, 2024
- Initiation Date
- Feb 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1520 units
Product Description
Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660; b) STERILE SMALL 2 PRONG SKIN HOOK (25754), Product Code 67105; c) STERILE NEWS TRACH HOOK(83300), Product Code 67810; d) STERILE LILLIE EAR HOOK DELICATE 7", Product Code I68655
Reason for Recall
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Code Information
a) 66660, UDI/DI 60653160052154 (case) 00653160052152 (each), Lot Numbers: 2023042790, 2023091190; b) 67105, UDI/DI 60653160061880 (case) 00653160061888 (each), Lot Numbers: 2023042690; c) 67810, UDI/DI 30653160196703 (case) 00653160196702 (each), Lot Numbers: 2023060790, 2023070790; d) I68655, UDI/DI 00653160317220 (case) 10653160317227 (each), Lot Numbers: 2023061290
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1435-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026