AVID Medical Recalls Neurological Sponges Due to Endotoxin Variability
AVID Medical, Inc. 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 risk of harm (endotoxin variability) where injury has not yet been reported, fitting the High severity criteria for risk-of-harm products without reported illness.
Plain-English summary
AVID Medical, Inc. is recalling specific lots of Ritmed Neurological Sponges Non-Sterile, Models 55992C through 55998C. The recall was initiated due to a Medicom Urgent Medical Device Recall.
The reason for the recall is the potential for unexpected variability of endotoxin levels on the products. The source text does not specify the number of affected units, specific lot numbers, or distribution states for this particular recall notice.
Consumers and healthcare facilities should check their inventory for the affected models and stop using them if they match the recalled description. No specific consumer action instructions beyond the recall initiation are provided in the source text.
The recalled product
- Product
- 1) NEURO, (kit) ACNE73-01; 2) NEURO, (kit) ACNE73-03; 3) CRANI, (kit) AKCR19-01; 4) ORTHO SPINE PACK, (kit) ARMC017; 5) BMHM NEURO PACK, (kit) BMHT016-05; 6) LUMBAR PACK, (kit) BMHT112-03; 7) NEURO LAMINECTOMY PACK, (kit) DGNE75; 8) NEURO LAMINECTOMY PACK, (kit) DGN
- Manufacturer
- AVID Medical, Inc.
- Hazard
- Affected units
- 16,223
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 (kit) ACNE73-01
- UDI/DI 10809160458532
- Kit Lot Number 1649716
- Kit Lot Number 1666559
- Kit Lot Number 1649717
- Model/Item Number (kit) ACNE73-03
- UDI/DI 10809160513996
- Kit Lot Number 1696563
- Model/Item Number (kit) AKCR19-01
- UDI/DI 10809160459515
- Kit Lot Number 1650945
- Kit Lot Number 1666564
- Kit Lot Number 1664544
- Kit Lot Number 1666978
- Model/Item Number (kit) ARMC017
- UDI/DI 10809160506455
- Kit Lot Number 1685117
- Kit Lot Number 1688043
- Kit Lot Number 1688044
- Model/Item Number (kit) BMHT016-05
Distribution
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