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.
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: 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.
- Hazard
- metal-contamination
- foreign-body
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.
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