Medical Convenience Kits Recalled for Detachable Metal Flakes in Surgical Instruments
AVID Medical is recalling Halyard Shoulder Pack medical convenience kits because the sponge forceps and towel clamps contain loose metal flakes that could detach and enter a patient's surgical site during use, 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 for a risk-of-harm product (surgical instruments with potential for foreign body contamination during patient procedures). No illnesses or injuries have been reported, placing this at the maximum score for theoretical hazards with unexercised but significant risk of harm.
Plain-English summary
AVID Medical is recalling Halyard Shoulder Pack medical convenience kits (Model PANJ005) distributed nationwide. The recall affects units with lot numbers 1607501, 1608148, and 1608519.
Sponge forceps and towel clamps in these kits contain small loose metal flakes that can detach from the components. If these metal flakes enter a patient's surgical site undetected during a procedure, they may cause local reactions or foreign body reactions.
Healthcare facilities and individuals who have purchased these kits should stop using them immediately and contact AVID Medical for instructions.
The recalled product
- Product
- Halyard SHOULDER PACK - Medical convenience kits Model Number: PANJ005
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 96
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 (3)
- GTIN: 10809160321706 Lot Number: 1607501
- 1608148
- 1608519
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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