Halyard Angiography Drape Pack Recalled for Potential Metal Flakes in Surgical Site
AVID Medical recalls Halyard angiography drape packs due to potential metal flakes that could detach from sponge forceps and towel clamps. These flakes could enter a surgical site undetected 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 FDA Class II recall involves a medical device used in surgical procedures with potential for contamination of the surgical site by metal flakes. Although no illnesses or injuries have been reported, the potential for foreign body reactions in surgical patients constitutes a risk-of-harm scenario warranting a High severity rating.
Plain-English summary
AVID Medical, Inc. is recalling Halyard ANGIOGRAPHY DRAPE PACK (Model Number VMCC021-06, Lot Number 1572642) due to a potential safety issue involving metal flakes on sponge forceps and towel clamps.
Sponge forceps and towel clamps in the product may have small loose metal flakes that could detach from the components. If these metal flakes enter a surgical site undetected, they may cause local reactions or possible foreign body reactions in patients.
The affected product has been distributed nationwide in the United States. A total of 114 units are included in this recall.
The recalled product
- Product
- Halyard ANGIOGRAPHY DRAPE PACK - Medical convenience kits Model Number: VMCC021-06
- Manufacturer
- AVID Medical, Inc.
- Hazard
- Affected units
- 114
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: 10809160334287 Lot Number: 1572642
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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