AVID Medical Recalls Halyard C Section Bundles Due to Metal Flakes
AVID Medical, Inc. is recalling Halyard C Section Bundles because small metal flakes may detach from sponge forceps and towel clamps, posing a risk of 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves foreign body reactions in surgical sites, which constitutes a significant injury risk, aligning with the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
AVID Medical, Inc. is recalling 308 units of Halyard C Section Bundle medical convenience kits, Model Number LANC015-34. The recall covers products with GTIN 10809160380888 and Lot Numbers 1590497 and 1601534. These products were distributed nationwide in the United States.
The recall was initiated because small loose metal flakes associated with sponge forceps and towel clamps in the kits potentially 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 who have these specific medical convenience kits should stop using them immediately. AVID Medical, Inc. is the recalling firm and is responsible for managing the recall process.
The recalled product
- Product
- Halyard C SECTION BUNDLE - Medical convenience kits Model Number: LANC015-34
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 308
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: 10809160380888 Lot Number: 1590497
- 1601534
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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