FDAFDA · Food and drugs·Recall number Z-1442-2024
Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580; b) DEBRIDEMENT TRAY, Product Code I86630; c) BIOPSY INSTRUMENT PACK, Product Code I86690; d) DEBRIDEMENT TRAY, Product Code I86815; e) IR ADSON FORCEP & NEEDLE HOLDER, Product Code MNS12675; f) TOENAIL REMOVAL KIT, Product Code SUT20350 MEDLINE GENERAL PURPOSE INST. TRAY, Product Code DYNDA2346A
Published April 10, 2024 · Recall initiated: February 23, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Worldwide distribution - US Nationwide and the countries of Panama, Canada.
- Lot
- a) 66580, UDI/DI 10653160028963 (case) 00653160028966 (each), Lot Numbers: 2023041090; b) I86630, UDI/DI 00653160286540 (case) 10653160286547 (each), Lot Numbers: 2023101190; c) I86690, UDI/DI 00653160290752 (case) 10653160290759 (each), Lot Numbers: 2023103190; d) I86815, UDI/DI 00653160342291 (case) 10653160342298 (each), Lot Numbers: 2023112190; e) MNS12675, UDI/DI 00653160337341 (case) 10653160337348 (each), Lot Numbers: 2023070390; f) SUT20350, UDI/DI 00653160306552 (case) 10653160306559 (each), Lot Numbers: 2023022290, 2023041190, 2023042490, 2023052390, 2023101890 MEDLINE: UDI/DI 20193489191582 (case) 10193489191585 (each), Lot Numbers: 2023062290, 2023081490
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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