Halyard GYN TRAY surgical kits recalled for loose metal flakes
AVID Medical is recalling 136 units of Halyard GYN TRAY surgical kits due to small loose metal flakes that could detach from sponge forceps and towel clamps. These metal fragments could enter a patient's surgical site undetected, 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 recall for medical device with potential for foreign body in surgical site. The source describes the hazard using potential language ('could detach,' 'may enter') with no reported illnesses or injuries, fitting the 'risk-of-harm without reported injury' criterion for High severity.
Plain-English summary
AVID Medical, Inc. is recalling 136 units of the Halyard GYN TRAY (Model LANC014-19), a medical convenience kit used in gynecological procedures. The affected units were distributed nationwide and are identified by Lot Number 1597709.
The sponge forceps and towel clamps in these kits may have small loose metal flakes that could potentially detach from the components. Metal flakes that enter a patient's surgical site undetected could cause local reactions or possible foreign body reactions.
This is a Class II recall by the U.S. Food and Drug Administration.
The recalled product
- Product
- Halyard GYN TRAY - Medical convenience kits Model Number: LANC014-19
- Manufacturer
- AVID Medical, Inc.
- Hazard
- metal-flakes
- 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 (1)
- GTIN: 10809160368237 Lot Number: 1597709
Distribution
Distributed nationwide across the United States.
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