Halyard MINOR PACK Medical Kits Recalled for Loose Metal Fragments in Instruments
AVID Medical is recalling Halyard MINOR PACK medical kits because sponge forceps and towel clamps may shed loose metal fragments. These could enter surgical sites undetected, 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: This FDA Class II recall involves a manufacturing defect creating risk-of-harm in surgical contexts where no illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products without reported injury score at 3 (High).
Plain-English summary
AVID Medical, Inc. is recalling Halyard MINOR PACK medical convenience kits (Model Number MMOK013-03, Lot Number 1598132) due to a manufacturing defect in the sponge forceps and towel clamps. The instruments may contain small loose metal flakes that could potentially detach from the components.
If metal flakes detach and enter a patient's surgical site undetected, they could cause local tissue reactions or foreign body reactions. These conditions could result in patient discomfort, inflammation, or complications requiring additional treatment.
The affected kits were distributed nationwide. Healthcare facilities and medical professionals using this product should verify the lot number and implement appropriate measures to prevent use of recalled units.
The recalled product
- Product
- Halyard MINOR PACK - Medical convenience kits Model Number: MMOK013-03
- Manufacturer
- AVID Medical, Inc.
- Hazard
- foreign-body-risk
- 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: 10809160411995 Lot Number: 1598132
Distribution
Distributed nationwide across the United States.
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