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.
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 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.
- Hazard
- loose-metal-flakes
- 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 (3)
- GTIN: 10809160321706 Lot Number: 1607501
- 1608148
- 1608519
Distribution
Distributed nationwide across the United States.
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