Medical Convenience Kits Recalled for Detachable Metal Flakes
AVID Medical recalls Halyard TAH-BUNDLE medical kits with sponge forceps and towel clamps. Loose metal flakes may detach and enter surgical sites, potentially causing 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: FDA Class II medical device recall with potential for patient harm through foreign body contamination of surgical sites. No reported illnesses or injuries have been documented per the source material.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard TAH-BUNDLE medical convenience kits (model number LANC039-29) due to a manufacturing defect involving loose metal flakes. These flakes could potentially detach from the sponge forceps and towel clamps included in the kits.
If metal flakes are not detected during use, they may enter a patient's surgical site and cause local tissue reactions or foreign body reactions. This poses a risk to patient safety during surgical procedures.
The affected lot number is 1596722 (GTIN: 10809160368527). The kits have been distributed nationwide in the United States. Healthcare facilities using these kits should discontinue use immediately and contact AVID Medical or the FDA for return instructions. Patients who have been treated using these kits should consult with their healthcare provider if they experience any symptoms following their procedure.
The recalled product
- Product
- Halyard TAH-BUNDLE - Medical convenience kits Model Number: LANC039-29
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 12
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: 10809160368527 Lot Number: 1596722
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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