AVID Medical Recalls Heart Cath Lab Kits Due to Metal Flakes
AVID Medical is recalling 411 Heart Cath Lab Kits because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.
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: The recall involves a risk-of-harm product (foreign body reaction) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
AVID Medical, Inc. is recalling 411 units of the Halyard HEART CATH LAB PK, STRL F G (Model Number: MSBM003-03). These are medical convenience kits distributed nationwide in the United States. The specific lot number is 1587478, and the GTIN is 10809160410172.
The recall was initiated because sponge forceps and towel clamps associated with the kits may have small loose metal flakes that could detach from the components. If these metal flakes enter a patient's surgical site undetected, they may cause local reactions or possible foreign body reactions.
Healthcare facilities and consumers should stop using these kits and contact AVID Medical, Inc. for further instructions or a refund. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Halyard HEART CATH LAB PK, STRL F G - Medical convenience kits Model Number: MSBM003-03
- Manufacturer
- AVID Medical, Inc.
- Hazard
- Affected units
- 411
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: 10809160410172 Lot Number: 1587478
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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