Halyard Biopsy Pack surgical instruments recalled due to loose metal flakes
AVID Medical is recalling Halyard BIOPSY PACK surgical kits due to loose metal flakes from sponge forceps and towel clamps. Metal flakes could enter a patient's surgical site, potentially causing 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: Class II medical device with potential for foreign body contamination in surgical sites, but no reported injuries or illnesses. This meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' scoring High (3).
Plain-English summary
AVID Medical, Inc. is recalling Halyard BIOPSY PACK surgical convenience kits (Model Number VANW019-04, Lot Number 1609032) distributed nationwide in the United States. The recall was issued by the U.S. Food and Drug Administration.
The sponge forceps and towel clamps in these kits may have small, loose metal flakes that could detach from the components. If these metal flakes enter a patient's surgical site undetected during a procedure, they could cause local tissue reactions or foreign body reactions.
The affected lot (1609032) consisted of 88 units. Consumers and healthcare facilities should discontinue use of this product immediately and contact AVID Medical for replacement or return instructions.
If you have this product, do not use it and contact the manufacturer or your healthcare provider with questions about your safety.
The recalled product
- Product
- Halyard BIOPSY PACK - Medical convenience kits Model Number: VANW019-04
- Manufacturer
- AVID Medical, Inc.
- Hazard
- foreign-body
- device-defect
- metal-contamination
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: 10809160379462 Lot Number: 1609032
Distribution
Distributed nationwide across the United States.
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