AVID Medical Recalls Halyard Laparoscopy Trays Due to Metal Flakes
AVID Medical is recalling 42 Halyard Laparoscopy Trays 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 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 and involves a risk of foreign body reactions in patients, which aligns with the rubric criteria for Severe severity involving significant injury reports or high-risk medical device defects.
Plain-English summary
AVID Medical, Inc. is recalling 42 units of the Halyard Laparoscopy Tray (Model Number: LANC006-25). The recall was initiated because sponge forceps and towel clamps associated with the kits may release small loose metal flakes.
These metal flakes could detach from the components and potentially enter a patient's surgical site undetected. This may cause local reactions or possible foreign body reactions.
The affected products were distributed nationwide in the United States. The specific lot number is 1603717 and the GTIN is 10809160368169. Healthcare facilities should stop using these kits and contact AVID Medical for instructions on returning the product.
The recalled product
- Product
- Halyard LAPAROSCOPY TRAY - Medical convenience kits Model Number: LANC006-25
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 42
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: 10809160368169 Lot Number: 1603717
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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