Halyard Shoulder Medical Kit recalled for loose metal flakes in surgical components
AVID Medical is recalling Halyard shoulder surgical kits due to loose metal flakes that could detach and enter surgical sites. Metal debris could cause 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 medical device recall presents a risk of foreign body contamination in surgical sites. No injuries or illnesses have been reported. The hazard is theoretical—loose metal flakes could detach and cause local or foreign body reactions, but no incidents have been documented.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard KIT, SHOULDER (Model Number ESJH014-06), a medical convenience kit used in surgical procedures. The recall affects 42 units that were distributed nationwide in the United States.
The sponge forceps and towel clamps included in these kits may have small loose metal flakes that could detach from the components. If these metal flakes enter a patient's surgical site undetected, they could cause local reactions or possible foreign body reactions.
The recall applies to all units bearing Lot Number 1610214 with GTIN 10809160423226. Healthcare facilities and surgical centers that have received these kits should identify and isolate affected units.
Patients who have undergone surgery using these kits and experience symptoms of foreign body reaction or unusual local reactions at the surgical site should contact their healthcare provider immediately. Healthcare facilities should contact AVID Medical, Inc. for instructions on returning or replacing affected units.
The recalled product
- Product
- Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06
- Manufacturer
- AVID Medical, Inc.
- Hazard
- foreign-body
- metal-contamination
- surgical-site-reaction
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: 10809160423226 Lot Number: 1610214
Distribution
Distributed nationwide across the United States.
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