Medline Centurion Procedure Kits Recalled for Syringe Quality Issues
Medline is recalling Centurion procedure kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert regarding leaks and breakage.
What this means for you
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: The recall is classified as FDA Class II, and the source text explicitly states that the quality issues 'may pose a risk to patient health' without reporting specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling specific Centurion procedure kits, including arthrogram trays, biopsy kits, and OB delivery trays. The recall is due to the inclusion of plastic syringes that are affected by an FDA Safety Alert issued on March 19, 2024.
The affected syringes have identified quality issues, including leaks and breakage, which may pose a risk to patient health. The recall covers kits distributed worldwide with specific pack numbers and lot numbers listed in the agency's structured data.
Healthcare facilities and consumers should stop using these specific kits and contact Medline Industries for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Centurion procedure kits, labeled as: 1) ARTHROGRAM TRAY, Pack Number DYNDH1349; 2) ARTHROGRAM TRAY-LF, Pack Number SPEC0400; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 4) BIOPSY KIT, Pack Number DYNDH1570; 5) BIOPSY TRAY-LF, Pack Number SPEC4380; 6) BMA BX
- 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 (20)
- DYNDH1349
- Lot Number 2019061090
- SPEC0400
- Lot Number 2022010790
- Lot Number 2022061490
- PT220
- Lot Number 2020090390
- DYNDH1570
- Lot Number 2023091390
- SPEC4380
- Lot Number 2023110890
- DYNDH1050A
- Lot Number 2019100490
- SPEC0130C
- Lot Number 2020072090
- DT5490B
- Lot Number 2022091590
- S5078BF09
- Lot Number 2022122390
- CHT705
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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