AVID Medical Recalls Halyard GYN PAC Kits Due to Metal Flakes
AVID Medical is recalling Halyard GYN PAC medical convenience kits because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.
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: The recall involves a risk-of-harm product where injury has not yet been reported, specifically the potential for foreign body reactions from metal flakes entering a surgical site.
Plain-English summary
AVID Medical, Inc. is recalling Halyard GYN PAC medical convenience kits, model number SJGY20-02. The recall involves 36 units distributed nationwide in the United States. The specific lot number is 1604218 and the GTIN is 10809160420089.
The recall is being issued because sponge forceps and towel clamps associated with these kits may release small loose metal flakes. These metal flakes could detach from the components and potentially enter a patient's surgical site undetected. This may cause local reactions or possible foreign body reactions.
Healthcare facilities and consumers should stop using the affected kits and contact AVID Medical, Inc. for instructions on returning the product or obtaining a replacement.
The recalled product
- Product
- Halyard GYN PAC - Medical convenience kits Model Number: SJGY20-02
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 36
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: 10809160420089 Lot Number: 1604218
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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