Transport bag kits recalled over a Tyvek bag seal issue
AVID Medical is recalling 1,500 Halyard Transport Bag Kits because a Tyvek bag seal issue may compromise the sterility of the kit.
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: Scored 3 under the risk-of-harm criterion: the firm states the seal issue may compromise sterility of the kit, and no injuries are reported.
Plain-English summary
The Halyard Transport Bag Kit, kit code LIFE0080-01, is being recalled by AVID Medical, Inc.
The reason given in the enforcement record is a Tyvek bag seal issue which may compromise sterility of the kit.
The record lists 1,500 units under kit code LIFE0080-01, UDI-DI 10809160314500, lot number 1650056, expiration date 07/24/2028. The record gives distribution as US nationwide in the states of New Jersey. The FDA has classified the action as Class II.
Sterility that cannot be assured carries an infection risk. The enforcement record reports no injuries. Facilities should quarantine the affected lot and follow AVID Medical's instructions.
The recalled product
- Product
- Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Procedure kit
- Affected units
- 1,500
Distribution
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