Halyard EP TRAY Surgical Kits Recalled for Loose Metal Flakes
AVID Medical is recalling Halyard EP TRAY surgical convenience kits due to sponge forceps and towel clamps that may shed small metal flakes. These flakes could enter surgical sites, potentially causing local or foreign body reactions.
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: This is an FDA Class II recall for loose metal components in surgical instruments. No illnesses or injuries are reported in the source text. The hazard—metal flakes potentially entering surgical sites—presents a theoretical risk of local or foreign body reactions, but without confirmed harm, the severity is High rather than Severe per the rubric.
Plain-English summary
AVID Medical, Inc. is recalling Halyard EP TRAY Medical Convenience Kits (Model Number VAST038-04) distributed nationwide in the United States. The sponge forceps and towel clamps included in these kits may have small loose metal flakes that could detach from the components.
The detached metal flakes could undetectably enter a patient's surgical site, potentially causing local reactions or foreign body reactions. This hazard affects healthcare facilities and surgical centers using these kits.
Patients who have undergone surgery using equipment from affected kits should contact their healthcare provider if they experience unusual symptoms or complications. Healthcare facilities should cease use of affected kits immediately and contact AVID Medical, Inc. for recall instructions and replacement products.
The recalled product
- Product
- Halyard EP TRAY - Medical convenience kits Model Number: VAST038-04
- Manufacturer
- AVID Medical, Inc.
- Hazard
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 (1)
- GTIN: 10809160367995 Lot Number: 1595421
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 73 recalled by AVID Medical, 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.
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