Halyard ORTHO PACK surgical instrument kits recalled due to metal flakes
AVID Medical is recalling Halyard ORTHO PACK kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site, 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: FDA Class II medical device recall with no reported illnesses or injuries. The hazard involves theoretical risk of metal fragments entering surgical sites, which could cause patient reactions, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
AVID Medical, Inc. is recalling Halyard ORTHO PACK medical convenience kits (Model MMOK006-04) distributed nationwide in the United States. The recalled kits contain sponge forceps and towel clamps.
The kits have loose metal flakes on the forceps and clamp components that could potentially detach. These metal flakes may enter a patient's surgical site undetected.
Metal fragments in a surgical site could cause local reactions or foreign body reactions in patients. Users who have these kits should stop using them and contact AVID Medical for further instructions.
The recalled product
- Product
- Halyard ORTHO PACK -Medical convenience kits Model Number: MMOK006-04
- Manufacturer
- AVID Medical, Inc.
- Hazard
- metal-fragments
- 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 (2)
- GTIN: 10809160404201 Lot Number: 1597105
- 1605626
Distribution
Distributed nationwide across the United States.
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