Medical Convenience Kits Recalled for Potential Loose Metal Flakes in Surgical Instruments
AVID Medical is recalling Halyard MANIFOLD CATH PACK medical convenience kits because sponge forceps and towel clamps may shed metal flakes that could contaminate surgical sites.
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 an FDA Class II medical device recall with potential foreign body and contamination risk in surgical contexts, but without reported illnesses or injuries. Per the rubric, risk-of-harm products without confirmed injury are scored at 3 (High).
Plain-English summary
AVID Medical, Inc. is recalling Halyard MANIFOLD CATH PACK medical convenience kits (Model VMED005-03) due to potential metal flakes that may detach from sponge forceps and towel clamps included in the kits. The affected lot numbers are 1599372 and 1607988. A total of 232 units were distributed nationwide.
Metal flakes from the surgical instruments may enter a patient's surgical site undetected, potentially causing local reactions or foreign body reactions.
Healthcare providers and patients using these kits should discontinue use immediately and contact AVID Medical, Inc. with questions or to report any adverse events related to this recall.
The recalled product
- Product
- Halyard MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 232
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: 10809160334904 Lot Number: 1599372
- 1607988
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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