Halyard Anterior Hip Pack surgical kits recalled due to loose metal flakes
AVID Medical is recalling Halyard Anterior Hip Pack surgical kits because sponge forceps and towel clamps may have loose metal flakes that could detach, enter a patient's surgical site undetected, and cause local or foreign body reactions.
What this means for you
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 recall involving surgical instruments with loose metal components that could cause foreign body injuries. No illnesses or injuries have been reported. This qualifies as a risk-of-harm product where injury has not yet occurred.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard Anterior Hip Pack (Model Number EUOR001-06), a medical convenience kit containing surgical instruments. The affected lot numbers are 1610366, 1610367, 1610368, and 1610369, with 144 units distributed nationwide in the United States.
The sponge forceps and towel clamps may have small loose metal flakes on their components that could detach during surgical use.
If metal flakes detach and enter a patient's surgical site undetected, they may cause local reactions or foreign body reactions. The Food and Drug Administration has classified this as a Class II recall.
The recalled product
- Product
- Halyard ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06
- Manufacturer
- AVID Medical, Inc.
- Hazard
- metal-flakes
- foreign-body-risk
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 (4)
- GTIN: 10809160423981 Lot Number: 1610366
- 1610367
- 1610368
- 1610369
Distribution
Distributed nationwide across the United States.
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