AVID Medical Recalls Halyard Neurological Sponges Due to Endotoxin Variability
AVID Medical is recalling specific lots of Halyard medical convenience kits containing Ritmed Neurological Sponges due to potential endotoxin level variability.
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 is classified as FDA Class II. The hazard involves potential endotoxin variability, which is a risk-of-harm condition for medical devices, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
AVID Medical, Inc. is recalling 816 Halyard medical convenience kits, including A-P, Posterior, Aneurysm, Spine, Anterior Cervical, and Crani packs. The recall involves specific lots of Ritmed Neurological Sponges (Non-Sterile, Models 55992C to 55998C) contained within these kits.
The recall was initiated due to a potential for unexpected variability of endotoxin levels in the sponges. The affected products were distributed nationwide in the states of AZ, CA, CO, WA, WY, TX, MI, FL, MD, UT, NC, MS, PA, MO, IA, NE, OH, IL, SD, MN, and GA.
Healthcare facilities and consumers should check their inventory for the specific model and lot numbers listed in the recall notice. If the affected products are found, they should be removed from use and returned to AVID Medical, Inc. or the distributor.
The recalled product
- Product
- Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01; 2) POSTERIOR PACK - 205960, Model/Item Number (kit) ANPP15-01; 3) ANEURYSM PACK, Model/Item Number (kit) BPAY14-01; 4) SPINE PACK, Model/Item Number (kit) HSLM53-01; 5
- Manufacturer
- AVID Medical, Inc.
- Hazard
- Affected units
- 816
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) ANAP22-01
- UDI/DI 10809160473146
- Kit Lot Number 346967
- Kit Lot Number 346982
- Model/Item Number (kit) ANPP15-01
- UDI/DI 10809160473573
- Kit Lot Number 343413
- Kit Lot Number 343414
- Kit Lot Number 343713
- Kit Lot Number 343715
- Kit Lot Number 343716
- Kit Lot Number 343412
- Kit Lot Number 343416
- Kit Lot Number 343714
- Kit Lot Number 343717
- Kit Lot Number 343718
- Kit Lot Number 343719
- Kit Lot Number 343723
- Model/Item Number (kit) BPAY14-01
- UDI/DI 10809160473979
Distribution
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