Surgical Sponge Forceps and Towel Clamps Recalled for Loose Metal Flakes
AVID Medical is recalling Halyard CATH LAB PACK surgical kits because sponge forceps and towel clamp components may shed loose metal flakes that could enter a patient's surgical site, posing a risk of 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 a risk-of-harm product (surgical device with foreign body contamination potential) where no injuries or illnesses have been reported. The hazard is theoretical—metal flakes may potentially detach and cause harm if they enter a surgical site, but no actual incidents have occurred. Per the severity rubric, this corresponds to High (3).
Plain-English summary
AVID Medical, Inc. is recalling Halyard CATH LAB PACK medical convenience kits (Model Number VANW016-05, Lot Number 1603736). The sponge forceps and towel clamp components in these kits are associated with small loose metal flakes that have the potential to detach during use.
Metal flakes on these components may enter a patient's surgical site undetected. If this occurs, the flakes could cause local reactions or foreign body reactions, posing a risk to patient safety.
The recalled kits have been distributed nationwide throughout the United States. This is a Class II recall issued by the U.S. Food and Drug Administration.
The recalled product
- Product
- Halyard CATH LAB PACK - Medical convenience kits Model Number: VANW016-05
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- metal-contamination
- foreign-body
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: 10809160332719 Lot Number: 1603736
Distribution
Distributed nationwide across the United States.
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