Z-1445-2024 Class II Ongoing
FDA device recall Z-1445-2024 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: 23,290 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 10, 2024
- Initiation Date
- Feb 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23,290 units
Product Description
Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Product Code 60265 MEDLINE manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code 60280; b) SUTURE REMOVAL TRAY, Product Code 86125; c) SUTURE REMOVAL KIT, Product Code SR60555; d) SKIN STAPLE REMOVER, Product Code TRI44105
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) TRI55405, UDI/DI 20193489112709 (case) 10193489112702 (each), Lot Numbers: 2023022390 b) 60265, UDI/DI 50653160090982 (case) 00653160090987 (each), Lot Numbers: 2023041190 MEDLINE: a) 60280, UDI/DI 20193489111948 I(case) 10193489111941 (each), Lot Numbers: 2023031790, 2023070590, 2023112790; b) 86125, UDI/DI 20193489111832 (case) 10193489111835 (each), Lot Numbers: 2023032090, 2023120490; c) SR60555, UDI/DI 20193489111955 (case) 10193489111958 (each), Lot Numbers: 2023111590; d) TRI44105, UDI/DI 20193489112730 (case) 10193489112733 (each), Lot Numbers: 2023072490
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1445-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026