Halyard Angiography Pack Surgical Instruments Recalled Due to Loose Metal Flakes
AVID Medical is recalling Halyard angiography pack surgical instruments due to loose metal flakes that could detach and enter a patient's surgical site, potentially causing foreign body reactions.
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 3/5 (High).
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 of surgical instruments with potential for serious harm through foreign body reactions, but no injuries or illnesses have been reported. The hazard is risk-of-harm based on the potential for metal fragments in a surgical site without documented incidents.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard ANGIOGRAPHY PACK, Model Number MAMC218-18, a medical convenience kit containing sponge forceps and towel clamps. Affected lot numbers are 1591425 and 1597157.
The recalled components are associated with small loose metal flakes that may detach from the sponge forceps and towel clamps. If undetected, these metal flakes could enter a patient's surgical site and cause local reactions or foreign body reactions.
These kits have been distributed nationwide throughout the United States.
The recalled product
- Product
- Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18
- Manufacturer
- AVID Medical, Inc.
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 (2)
- GTIN: 10809160316436 Lot Number: 1591425
- 1597157
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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