Centurion Medical Products Recalls Sterile Fluoro SSP Trays Due to Packaging Concerns
Centurion Medical Products is recalling 400 sterile fluoro SSP trays because the sterile packaging may be compromised. The kits are used for arthrogram injection and aspiration.
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. The hazard involves a potential compromise of sterile packaging, which poses a risk of infection, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Centurion Medical Products Corporation is recalling 400 units of the Sterile Fluoro SSP Tray (Kit Code: MNS11605). The recall is due to a potential for the sterile packaging to be compromised. The affected lot number is 2019020590, with an expiration date of 8/31/2020.
These kits are used for arthrogram injection and aspiration in the diagnostic section of the radiology department by medical professionals in a clinical setting. The products were distributed nationwide in the states of AZ, CA, FL, GA, IL, KY, MA, MD, MI, NC, NH, NY, OH, SC, TX, TN, VA, WA, and WI.
The FDA has classified this as a Class II recall. Medical professionals should stop using the affected kits and contact the manufacturer for further instructions.
The recalled product
- Product
- STERILE FLUORO SSP TRAY Kit Code: MNS11605 - Product Usage: This kit is used for arthrogram injection and aspiration. The kits are used in the diagnostic section of the radiology department, by medical professionals in a clinical setting.
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Kits
- Affected units
- 400
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 (1)
- Lot # 2019020590 Exp : 8/31/2020
Distribution
Part of a larger recall action
This product is one of 13 recalled by Centurion Medical Products Corporation 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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