Medline Centurion Manual Surgical Kits Recalled for Weak Seal Risk
Medline Industries is recalling 1700 units of Centurion Manual surgical kits due to potential weak seals that could compromise sterility. The weak seal may not be detectable by users.
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 FDA Class II recall involves a potential weak seal on medical device packaging that could compromise the sterility of surgical kit contents. While no illnesses or injuries have been reported, the undetectable nature of the seal defect creates a risk of harm if seals fail during use, fitting the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Medline Industries, LP is recalling 1700 units of Centurion Manual surgical kits due to a potential weak seal in the packaging. The affected products include 15ML Sampling Tubes with Caps (Product Code 15MLVLCP, Lot 2023102790) and Sterile 9x12 Reclosable Bags (Product Code MG912ST, Lot 2023022190).
The weak seal may not be visually detectable by users. If the seal fails, it may result in a breach of sterility, potentially exposing the contents to contamination and affecting the safety of medical procedures where these kits are used.
The affected products were distributed nationwide in the United States as well as in Panama and Canada. Healthcare facilities and users in possession of these kits should cease use, contact Medline Industries regarding the recall, and follow proper procedures for handling and disposing of the affected medical devices.
The recalled product
- Product
- Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code 15MLVLCP; b) STERILE 9X12 RECLOSABLE BAG, Product Code MG912ST
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Affected units
- 1,700
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 (5)
- a) 15MLVLCP
- UDI/DI 50653160021306 (case) 00653160021301 (each)
- Lot Numbers: 2023102790 b) MG912ST
- UDI/DI 10653160122906 (case) 00653160122909 (each)
- Lot Numbers: 2023022190
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 29 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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