Medline Centurion Medical Procedure Kits Recalled for Sterility Risk
Medline is recalling 168 Centurion medical procedure kits because packaging defects may allow non-sterile product use if the vendor seal is compromised.
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 involves a risk of using non-sterile medical devices, which poses a significant risk of harm (infection) even though no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Medline Industries, LP is recalling 168 units of Centurion brand medical procedure convenience kits. The affected products are labeled as "FLOOR - UMBILICAL CUT DOWN TRA" and "PLASTICS SUTURE TRAY." These kits were distributed nationwide in the United States, as well as in Canada and Panama.
The recall was initiated because the kits were packaged in breather pouches (lot 323080002) that may result in the potential use of non-sterile product if the vendor seal of the pouch is opened or unsealed. The specific lot numbers for the affected kits are 23LBO858 and 23LBL653.
Healthcare facilities and consumers should check their inventory for these specific lot numbers and UDI/DI codes. If the vendor seal is compromised, the product should not be used. Users should contact Medline Industries for further instructions on returning or disposing of the affected units.
The recalled product
- Product
- Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTURE TRAY
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Affected units
- 168
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 (6)
- a) UDI/DI 40653160270929 (each)
- 10653160270928 (case)
- Lot Numbers: 23LBO858
- b) UDI/DI 40653160284346 (each)
- 10653160284345 (case)
- Lot Numbers: 23LBL653
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 33 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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