Medical surgical kits recalled for loose metal flakes in instruments
AVID Medical is recalling Halyard CYSTO PDS medical convenience kits due to loose metal flakes that may detach from sponge forceps and towel clamps. These flakes could enter a surgical site and cause 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 is an FDA Class II recall with no reported illnesses or injuries. The hazard involves potential metal flake contamination of surgical sites, which represents a risk of harm (foreign body reactions) without confirmed injury. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
AVID Medical, Inc. is recalling Halyard CYSTO PDS medical convenience kits (Model GVVA002-05, Lot Number 1597182) distributed nationwide to hospitals and surgical facilities.
The sponge forceps and towel clamps in these kits may contain small loose metal flakes that could detach from the components during use. These flakes could enter a patient's surgical site undetected and potentially cause local reactions or foreign body reactions.
The recall affects medical convenience kits with GTIN 10809160398951 and Lot Number 1597182. No illnesses or injuries have been reported to date.
Healthcare facilities that have received these kits should discontinue use immediately and contact AVID Medical for instructions on returns or replacement products.
The recalled product
- Product
- Halyard CYSTO PDS - Medical convenience kits Model Number: GVVA002-05
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 14
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: 10809160398951 Lot Number: 1597182
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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