Halyard Angio Tray surgical kits recalled for loose metal flakes
AVID Medical recalls Halyard ANGIO TRAY (Model VAPX021-05) surgical kits due to potential loose metal flakes on forceps and clamps that could enter surgical sites and cause 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 recall involves an FDA Class II medical device with a theoretical hazard (loose metal flakes potentially entering surgical sites) and no reported illnesses or injuries. Per the severity rubric, risk-of-harm products without reported injury are classified as High.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard ANGIO TRAY surgical convenience kits (Model VAPX021-05, Lot Numbers 1594310 and 1600532). These kits were distributed nationwide in the United States, affecting approximately 138 units.
The recalled kits contain sponge forceps and towel clamps that may have small loose metal flakes on their components. These metal flakes have the potential to detach and enter a patient's surgical site without being detected. If metal debris enters the surgical site, it could cause local reactions or foreign body reactions.
The recalled product
- Product
- Halyard ANGIO TRAY - Medical convenience kits Model Number: VAPX021-05
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 138
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 (2)
- GTIN: 10809160381243 Lot Number: 1594310
- 1600532
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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