Halyard Pacemaker Tray Surgical Kits Recalled for Loose Metal Flakes
AVID Medical recalls Halyard PACEMAKER TRAY surgical kits nationwide due to potential loose metal flakes that could detach from sponge forceps and towel clamps and contaminate surgical sites.
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 Class II recall presents a risk-of-harm hazard (potential foreign body contamination in a sterile surgical field). No illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury are scored 3 (High).
Plain-English summary
AVID Medical, Inc. is recalling Halyard PACEMAKER TRAY medical convenience kits (Model Number VMPB0003-10, Lot Number 1599244) distributed nationwide in the United States. The recall affects surgical trays containing sponge forceps and towel clamps.
The sponge forceps and towel clamps may contain small loose metal flakes that could potentially detach from the components. These metal flakes could enter a patient's surgical site undetected and cause local reactions or foreign body reactions.
Healthcare facilities and surgical centers that have received this lot should discontinue use immediately. Patients who underwent surgery using the recalled product should contact their healthcare provider if they experience any complications or unusual symptoms.
The recalled product
- Product
- Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 6
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: 10809160335536 Lot Number: 1599244
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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