Ritmed Neurological Sponges Recalled Due to Potential Endotoxin Level Variability
Medicom is recalling specific lots of Ritmed Neurological Sponges (Models 55992C to 55998C) because of potential unexpected variability in endotoxin levels.
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 high-risk hazard (endotoxin variability) where injury has not yet been reported.
Plain-English summary
Medicom is recalling specific lots of Ritmed Neurological Sponges, non-sterile models 55992C through 55998C. This action was initiated due to the potential for unexpected variability in the endotoxin levels found on the products.
The affected products include AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits, specifically ENT Pack (Pack Numbers AMS12206, AMS15517) and ENT Facial Pack (Pack Number AMS15863A). These products were distributed nationwide in several US states, including AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, and WA.
Users should check their inventory for the specified pack numbers and lot numbers to determine if they have been affected by this recall.
The recalled product
- Product
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206; 2) ENT Pack, Pack Number AMS15517; 3) ENT Facial Pack, Pack Number AMS15863A.
- Manufacturer
- Windstone Medical Packaging, Inc.
- Hazard
- Affected units
- 919
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 (20)
- 1) Pack Number AMS12206
- UDI B098AMS122060
- Lot Numbers: 201002
- 205119
- 206649
- 211870
- 215233
- 217552
- 218967
- 219166
- 222076
- 224914
- 227000
- 228485
- 230336
- 231348
- 232214
- 238290
- 239795
- 241802. 2) Pack Number AMS15517
Distribution
Part of a larger recall action
This product is one of 4 recalled by Windstone Medical Packaging, 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.
See all 4 products in this recall →Related recalls
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