Halyard Surgical Kit Components May Shed Metal Flakes
AVID Medical is recalling Halyard ANGIO ARTERIOGRAM PACK surgical kits due to metal flakes that may detach from forceps and clamps. Metal fragments could enter a patient's surgical site and cause local or foreign body reactions.
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: This is a Class II medical device recall involving risk-of-harm from potential metal fragment contamination of surgical sites. No injuries or hospitalizations have been reported, placing it in the category of risk-of-harm products where injury has not yet been reported.
Plain-English summary
AVID Medical, Inc. is recalling Halyard ANGIO ARTERIOGRAM PACK Model MMCC004-01 surgical convenience kits, with a total of 176 units distributed nationwide in the United States. The sponge forceps and towel clamps included in the kits may have small loose metal flakes that could detach from the components during use. If metal flakes enter a patient's surgical site undetected, they could cause local reactions or foreign body reactions. Healthcare facilities using affected lots 1605588 and 1605589 should discontinue use and contact AVID Medical, Inc. for guidance on proper disposal and replacement options.
The recalled product
- Product
- Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC004-01
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 176
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: 10809160421772 Lot Number: 1605588
- 1605589
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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