Halyard Lower Extremity Pack surgical kits recalled for loose metal fragments
AVID Medical is recalling Halyard Lower Extremity Pack surgical kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site undetected, potentially causing local or 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 FDA Class II recall involves a risk-of-harm product (surgical instruments) but no illnesses or injuries have been reported. The hazard is theoretical, as metal flakes could potentially enter surgical sites. Per the rubric, this scores 3 (High) for risk-of-harm products where injury has not yet been reported.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard Lower Extremity Pack (Model Number PANJ001-03), a medical convenience kit used in surgical procedures. The affected lot numbers are 1608129, 1608518, and 1610934. The product was distributed nationwide across the United States.
The sponge forceps and towel clamps included in these kits may have loose metal flakes that could detach from the components. These metal flakes could enter a patient's surgical site undetected, potentially causing local reactions or foreign body reactions.
Healthcare facilities that received these products should not use them and should contact AVID Medical, Inc. for further instructions. Patients who may have been affected by this product should consult with their healthcare provider if they have concerns.
The recalled product
- Product
- Halyard LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ001-03
- Manufacturer
- AVID Medical, Inc.
- Hazard
- 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: 10809160321676 Lot Number: 1608129
- 1608518
- 1610934
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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