Halyard IVR Vascular Pack Surgical Instruments Recalled for Loose Metal Components
AVID Medical is recalling Halyard IVR Vascular Pack surgical kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site.
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 an FDA Class II recall involving loose metal contamination in surgical instruments with risk of foreign body reactions in patients. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3). No illnesses or injuries have been reported in the source.
Plain-English summary
AVID Medical, Inc. is recalling Halyard IVR VASCULAR PACK (Model Number: VAST027-08) medical convenience kits nationwide. The recall affects sponge forceps and towel clamps in kits distributed with Lot Numbers 1608916 and 1608917.
The recalled components may shed small loose metal flakes that could detach and enter a patient's surgical site undetected. If metal flakes enter the surgical field, they may cause local tissue reactions or foreign body reactions.
Healthcare providers and surgical facilities that received these kits should contact AVID Medical for further instructions regarding the recalled products and lots.
The recalled product
- Product
- Halyard IVR VASCULAR PACK - Medical convenience kits Model Number: VAST027-08
- Manufacturer
- AVID Medical, Inc.
- Hazard
- foreign-body
- metal-flakes
- 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 (2)
- GTIN: 10809160416303 Lot Number: 1608916
- 1608917
Distribution
Distributed nationwide across the United States.
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