Medline Recalls Non-Sterile MTO Protection Station Plus Kits
Medline is recalling 80 non-sterile MTO Protection Station Plus kits because they were sold to facilities without sterilization capabilities.
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: The recall is classified as FDA Class II and involves a risk-of-harm product (non-sterile medical device sold without sterilization capability) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Medline Industries Inc is recalling 80 units of Kit Model #650304917, MTO Protection Station Plus with Drape. These kits are intended to be sterilized prior to use but were sold to accounts that do not have the capability to perform sterilization.
The recall involves Lot 5550988, manufactured on November 22, 2019, and a second included lot with an unidentified lot number and expiration date. The affected products were distributed nationwide, including in California, Colorado, Connecticut, Ohio, Texas, and New York.
The FDA has classified this as a Class II recall. Users should stop using the affected kits and contact Medline Industries Inc for further instructions.
The recalled product
- Product
- Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and…
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Surgical Kits
- Affected units
- 80
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 (2)
- Lot 5550988. Exp not identified but manufactured 11/22/2019
- Second included lot with unidentified lot number and no identified exp
Distribution
Part of a larger recall action
This product is one of 8 recalled by Medline Industries Inc 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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