Centurion Universal Block Tray Recalled for Potential Sterile Packaging Compromise
Centurion Medical Products is recalling Universal Block Tray kits because sterile packaging may be compromised, posing a risk of infection during regional anesthesia.
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 involves a medical device with a potential sterile barrier failure, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Centurion Medical Products Corporation is recalling 4,560 units of the Universal Block Tray (Kit Code: MNS6645). The recall is due to a potential for the sterile packaging to be compromised. These kits are used for regional anesthesia nerve blocks for the general population.
The affected products are identified by Lot # 2019012290 and have an expiration date of 7/31/2021. 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.
Healthcare providers and consumers should stop using these kits immediately. The compromised sterile packaging presents a risk of introducing non-sterile materials into the patient during the procedure.
The recalled product
- Product
- UNIVERSAL BLOCK TRAY Kit Code: MNS6645 - Product Usage: Kit is used for regional anesthesia nerve blocks for general population.
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Anesthesia Kits
- Affected units
- 4,560
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 # 2019012290 Exp: 7/31/2021
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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