Medical procedure kits recalled due to defective plastic syringes
Medline's Centurion procedure kits are being recalled due to plastic syringes with leaks and breakage. The defective syringes may pose a risk to patient health during medical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of medical procedure kits with identified defects (leaks, breakage) in plastic syringes. No illnesses or injuries are reported in the source material. It qualifies as a risk-of-harm product without reported injury, fitting a score of 3 (High) per the severity rubric.
Plain-English summary
Medline Industries, LP is recalling multiple Centurion procedure kits worldwide because they contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. The affected kits include bone marrow trays, CT/ultrasound biopsy kits, fine laceration kits, infection driveline management kits, laceration trays, and suture trays with multiple specific lot numbers.
The plastic syringes in these kits have been identified with leaks, breakage, and other quality issues. These defects may pose a risk to patient health when the kits are used in medical procedures.
Any healthcare facility or medical professional using these kits should stop using affected products immediately and contact Medline Industries for replacement options or additional information about the recall.
The recalled product
- Product
- Centurion procedure kits labeled as: 1) BONE MARROW TRAY, Pack Number SPEC0255; 2) CT/ULTRASOUND BIOPSY, Pack Number SPEC0262; 3) FINE LACERATION KIT, Pack Number SUT17215; 4) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 5) LACERATION TRAY, Pack Number…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedure kits
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- SPEC0255
- Lot Number 2020042080: SPEC0262
- Lot Number 2018111280: SUT17215
- Lot Number 2020042080: DM645
- Lot Number 2018111280: DM645
- Lot Number 2022020780: DYNDL1159B
- Lot Number 2018111280: DYNDS1064B
- Lot Number 2020042080
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 8 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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