AVID Medical Recalls Halyard CPT PEDS ADULT CH PACK Surgical Kits
AVID Medical is recalling 81 units of Halyard CPT PEDS ADULT CH PACK surgical kits because sponge forceps and towel clamps may shed metal flakes.
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: The recall involves a risk-of-harm product (surgical instruments) where injury has not yet been reported, fitting the 'High' severity criteria for potential foreign body reactions.
Plain-English summary
AVID Medical, Inc. is recalling 81 units of the Halyard CPT PEDS ADULT CH PACK medical convenience kits, model number SHAN431-06. The affected units have the GTIN 10809160417126 and Lot Number 1599174. These products were distributed nationwide in the United States.
The recall is due to a defect where sponge forceps and towel clamps associated with the kits may have small loose metal flakes that could detach. If these metal flakes enter a patient's surgical site undetected, they may cause local reactions or possible foreign body reactions.
Healthcare facilities and consumers should stop using the affected kits immediately. Users should contact AVID Medical, Inc. for further instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-06
- Manufacturer
- AVID Medical, Inc.
- Hazard
- Affected units
- 81
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: 10809160417126 Lot Number: 1599174
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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