Halyard ENDOVASCULAR surgical kits recalled for loose metal flakes
Halyard ENDOVASCULAR Model VMED008-02 surgical convenience kits are recalled due to potential loose metal flakes in sponge forceps and towel clamps. These flakes could enter a surgical site 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 Class II medical device recall involves surgical instruments with potential for patient harm through introduction of foreign material into a surgical site. No illnesses or injuries have been reported. The hazard is theoretical but poses a documented risk of local or foreign body reactions.
Plain-English summary
Halyard ENDOVASCULAR Model VMED008-02 medical convenience kits, manufactured by AVID Medical, Inc., are subject to a Class II recall. The kits contain sponge forceps and towel clamps that may have loose metal flakes associated with the components.
The metal flakes could detach from the instruments and enter a patient's surgical site undetected. Once in the surgical field, these metal flakes may cause local reactions or foreign body reactions.
This recall affects Halyard ENDOVASCULAR kits distributed nationwide in the United States. Healthcare facilities using these kits should discontinue use and contact the manufacturer for instructions on returning affected units or receiving replacements. Lot numbers 1583502 and 1605477 are specifically identified in this recall.
The recalled product
- Product
- Halyard ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02
- Manufacturer
- AVID Medical, Inc.
- Hazard
- Affected units
- 24
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: 10809160334935 Lot Number: 1583502
- 1605477
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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