Medical Drainage Pack Components Recalled for Potential Metal Fragments
AVID Medical is recalling the Halyard IR Abcess Drainage Pack due to sponge forceps and towel clamps that may have loose metal flakes. Metal flakes could detach and enter a patient's surgical site, 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 a FDA Class II medical device recall for a documented product defect in surgical instruments. Although the potential hazard could result in patient harm, no illnesses or injuries have been reported in the source text. This meets the High severity criterion as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard IR Abcess Drainage Pack (Model AVMD018), a medical convenience kit used in surgical procedures. The sponge forceps and towel clamps included in the kit may have loose metal flakes that could detach from the components.
Metal flakes that detach could potentially enter a patient's surgical site without being detected. This poses a risk of local reactions or possible foreign body reactions requiring additional medical intervention.
The affected product was distributed nationwide with Lot Number 1600756. Healthcare providers should immediately stop using the affected kits. Facilities that have received this product should contact AVID Medical, Inc. for instructions regarding return or replacement of the recalled product.
The recalled product
- Product
- Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 80
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: 10809160304952 Lot Number: 1600756
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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