Surgical Instruments Recalled Due to Potential Metal Flake Contamination
AVID Medical recalled Halyard POST PARTUM TUBAL LIGATION surgical kit components due to loose metal flakes that could detach from sponge forceps and towel clamps. Metal flakes entering a patient's surgical site could cause 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: This is a Class II medical device recall involving surgical instruments. No illnesses or injuries have been reported in the source text. However, the hazard represents a genuine risk of harm—loose metal flakes could contaminate a surgical site and potentially cause local tissue reactions or foreign body reactions. Per the severity rubric, risk-of-harm products where injury has not yet been reported receive a Score 3 (High) rating.
Plain-English summary
AVID Medical, Inc. is recalling Halyard POST PARTUM TUBAL LIGATION surgical instrument kits (Model LANC026-19, Lot Number 1588253) that were distributed nationwide. The kits contain sponge forceps and towel clamps that may have loose metal flakes.
Small loose metal flakes are potentially able to detach from the sponge forceps and towel clamps. If metal flakes become detached and enter a patient's surgical site undetected during a tubal ligation procedure, they could cause local tissue reactions or foreign body reactions.
Healthcare facilities and surgical providers with this product should review the FDA recall notice for guidance and instructions. Patients who have had procedures using these instruments should discuss any concerns with their healthcare provider.
The recalled product
- Product
- Halyard POST PARTUM TUBAL LIGATION - Medical convenience kits Model Number: LANC026-19
- Manufacturer
- AVID Medical, Inc.
- Hazard
- metal-flakes
- foreign-body
- surgical-contamination
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: 10809160368367 Lot Number: 1588253
Distribution
Distributed nationwide across the United States.
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