Halyard cardiac surgical kit recalled for loose metal flakes risk
AVID Medical is recalling Halyard cardiac surgical kits (Model ESJH017-03) due to sponge forceps and towel clamps that may shed small metal flakes during surgery. These metal flakes could enter the patient's surgical site, potentially causing 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 is an FDA Class II recall involving surgical instruments with loose metal flakes that could enter a patient's surgical site. The source describes potential reactions but does not report actual illnesses or injuries. Per the rubric, a risk-of-harm product where injury has not been reported scores 3 (High).
Plain-English summary
AVID Medical, Inc. is recalling Halyard KIT, CARDIAC ROBOTIC (Model ESJH017-03), a surgical instrument kit containing sponge forceps and towel clamps. The affected product consists of 46 units distributed nationwide in the United States.
Small loose metal flakes are associated with the sponge forceps and towel clamps. These flakes could potentially detach from the components and enter a patient's surgical site undetected, causing local reactions or possible foreign body reactions.
The FDA has classified this as a Class II recall. Healthcare providers and facilities should be aware of this potential risk with the affected lot number 1600678.
The recalled product
- Product
- Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03
- Manufacturer
- AVID Medical, Inc.
- Hazard
- foreign-body
- metal-flakes
- surgical-contamination
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: 10809160406144 Lot Number: 1600678
Distribution
Distributed nationwide across the United States.
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