Medicom Recalls Neurological Sponges Due to Endotoxin Variability
Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile due to potential unexpected variability in endotoxin levels.
What this means for you
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 for unexpected variability in endotoxin levels, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile, Models 55992C to 55998C. The recall was initiated due to a potential for unexpected variability of endotoxin levels on the products.
The source text does not specify the number of units affected, the distribution scope, or the specific lot numbers involved in this recall. No illnesses or injuries have been reported in the provided text.
Consumers and healthcare facilities should check their inventory for the affected models and stop using them if they match the recalled description. They should contact Medicom for further instructions on how to return or dispose of the products.
The recalled product
- Product
- American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013, Model Item Number MHSP99AF.
- Manufacturer
- American Contract Systems Inc
- Hazard
- Affected units
- 160
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 (13)
- Model/Item Number MHAC65AH
- UDI/DI 191072211910
- Lot Number 42-8606211
- Lot Number 42-8687611
- Lot Number 42-8847511
- Model/Item Number MHSP99AF
- UDI/DI 191072214782
- Lot Number 42-8423411
- Lot Number 42-8470411
- Lot Number 42-8527611
- Lot Number 42-8601311
- Lot Number 42-8731511
- Lot Number 42-8795311.
Distribution
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