FDAFDA · Food and drugs·Recall number Z-2766-2024
Centurion procedure kits labeled as: 1) BIOPSY KIT, Pack Number DYNDA1466A; 2) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 3) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 4) CUSTOM BIOPSY TRAY, Pack Number MNS4815; 5) PERITONSILLAR ABSCESS TRAY, Pack Number MNS3560; 6) PRE POST DIALYSIS, Pack Number DYNDC3274; 7) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A
Published September 4, 2024 · Recall initiated: April 8, 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
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
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
- Lot
- DYNDA1466A, Lot Number 2022040190; SUT20455, Lot Number 2022040190; CHT560, Lot Number 2021092290; MNS4815, Lot Number 2022040190; MNS3560, Lot Number 2021021790; MNS3560, Lot Number 2021092290; MNS3560, Lot Number 2021092890; MNS3560, Lot Number 2022040190; MNS3560, Lot Number 2022071490; MNS3560, Lot Number 2023121290; DYNDC3274, Lot Number 2023121290; DYNDC2859A, Lot Number 2021092290
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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