Halyard Interventional Tray Medical Kits Recalled for Loose Metal Flakes
AVID Medical, Inc. is recalling the Halyard Interventional Tray medical kits because sponge forceps and towel clamps may shed small metal flakes. These loose flakes could enter a patient's surgical site undetected, 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 FDA Class II recall involves a risk-of-harm product where patients could suffer foreign body or local tissue reactions if metal flakes enter the surgical site. The source text does not report any actual illnesses or injuries, making the hazard theoretical, which aligns with a High severity score per the rubric.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard Interventional Tray medical convenience kits (Model Number PSSC004-03) distributed nationwide in the United States.
The recall affects sponge forceps and towel clamps included in the kits. Small loose metal flakes can potentially detach from these components during use. These flakes may enter a patient's surgical site undetected, which could cause local reactions or foreign body reactions.
The affected lot numbers are: 1608213, 1610445, 1611447, 1615322, and 1619673. A total of 300 units were distributed nationwide.
Healthcare facilities and providers who have received these kits should stop using them immediately and contact AVID Medical, Inc. for a replacement. Patients who may have been exposed to these kits should consult with their healthcare provider if they experience any unexpected reactions or symptoms following surgical procedures using this product.
The recalled product
- Product
- Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 300
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 (5)
- GTIN: 10809160348895 Lot Number: 1608213
- 1610445
- 1611447
- 1615322
- 1619673
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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