Surgical instrument kits recalled for potential loose metal flake hazard
Halyard abdominal procedure surgical kits may contain loose metal flakes in forceps and clamps that could enter the surgical site. Affected kits have lot number 1590888.
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 is a Class II FDA recall of a risk-of-harm surgical product. While no injuries or illnesses have been reported, the potential hazard—loose metal flakes entering a surgical site and causing foreign body reactions—meets the criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
AVID Medical, Inc. is recalling Halyard ABDOMINAL PROCEDURE medical convenience kits (Model Number GRAN015-06) distributed nationwide due to a potential hazard involving sponge forceps and towel clamps.
Small loose metal flakes may be present on or in these surgical instruments and potentially could detach during use. If these metal flakes enter a patient's surgical site undetected, they could cause local tissue reactions or foreign body reactions requiring additional medical attention.
The recalled kits have lot number 1590888 and have been distributed throughout the United States. Healthcare facilities that have received these kits should immediately quarantine them and contact AVID Medical, Inc. for instructions on return, replacement, or proper destruction of the affected products.
The recalled product
- Product
- Halyard ABDOMINAL PROCEDURE - Medical convenience kits Model Number: GRAN015-06
- Manufacturer
- AVID Medical, Inc.
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: 10809160366707 Lot Number: 1590888
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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