Surgical procedure kits recalled due to loose metal flakes in instruments
AVID Medical is recalling Halyard BASIC PROCEDURE PACK surgical instrument kits because sponge forceps and towel clamps may contain loose metal flakes that could enter a patient's surgical site and cause 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: No reported illnesses or injuries, and the hazard is theoretical (metal flakes 'could detach' and 'may enter'). The recall involves potential contamination in a surgical setting, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
AVID Medical, Inc. is recalling the Halyard BASIC PROCEDURE PACK (Model GRAN019-06, Lot 1587717), surgical instrument kits distributed nationwide. The packs contain sponge forceps and towel clamps.
Small loose metal flakes have been identified on the sponge forceps and towel clamps. These flakes could potentially detach during use.
If metal flakes enter a patient's surgical site undetected during a procedure, they may cause local tissue reactions or foreign body reactions. Any patient who underwent surgery using instruments from this lot could potentially be affected.
The FDA classified this as a Class II recall. Healthcare providers and facilities should contact AVID Medical regarding the affected product.
The recalled product
- Product
- Halyard BASIC PROCEDURE PACK - Medical convenience kits Model Number: GRAN019-06
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 24
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: 10809160365755 Lot Number: 1587717
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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