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 endotoxin variability, 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 through 55998C. The recall was initiated because of the 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 states where these products were sold. No illnesses or injuries have been reported in the provided text.
Healthcare facilities and consumers should check their inventory for the affected model numbers and lot numbers. If you have these products, contact the manufacturer or your medical device supplier for instructions on how to proceed.
The recalled product
- Product
- American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP57AI; 2) SPINE PACK, Model Item Number HSLM53AC; 3) CRANIAL PACK - 205992, Model Item Number MHCP75AH; 4) IMRI CRANI PACK - 213871, Model Item Number ANCI
- Manufacturer
- American Contract Systems Inc
- Hazard
- Affected units
- 4,789
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)
- Model/Item Number UDCP57AI
- UDI/DI 191072216250
- Lot Number 42-8388111
- Lot Number 42-8474311
- Lot Number 42-8521711
- Lot Number 42-8547611
- Lot Number 42-8672411
- Lot Number 42-8775211
- Lot Number 42-8810511
- Model/Item Number HSLM53AC
- UDI/DI 191072238207
- Lot Number 42-8447111
- Lot Number 42-8548311
- Lot Number 42-8630311
- Lot Number 42-8785011
- Lot Number 42-8742911
- Model/Item Number MHCP75AH
- UDI/DI 191072211934
- Lot Number 42-8455911
- Lot Number 42-8498111
Distribution
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