Surgical instrument kits recalled due to loose metal flakes
AVID Medical is recalling Halyard Upper Extremity Pack surgical kits because sponge forceps and towel clamps may shed small metal flakes. These flakes could enter a patient's surgical site, 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 medical devices with a defect that could introduce foreign material into a surgical site, a potential serious harm. No illnesses or injuries have been reported, and the hazard is theoretical, warranting a High severity classification.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard Upper Extremity Pack medical convenience kits (Model PANJ002-02). Sponge forceps and towel clamps included in these kits may develop small, loose metal flakes that could detach during surgical use.
If metal flakes detach from these surgical components, they could enter a patient's surgical site undetected and cause local reactions or foreign body reactions.
The affected kits were distributed nationwide across the United States. The recall involves Lot Numbers 1610935 and 1614208.
Healthcare facilities should contact AVID Medical, Inc. for further guidance regarding product replacement or return instructions.
The recalled product
- Product
- Halyard UPPER EXTREMITY PACK - Medical convenience kits Model Number: PANJ002-02
- Manufacturer
- AVID Medical, Inc.
- 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 (2)
- GTIN: 10809160321683 Lot Number: 1610935
- 1614208
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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