Electrophysiology lab packs recalled over a potentially incomplete header seal
AVID Medical is recalling 240 Halyard EP Lab packs over the potential for an incomplete seal on the header bag.
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: an incomplete package seal affects the sterile barrier of a procedure pack, and no injuries are reported.
Plain-English summary
The Halyard EP LAB PK, catalog number ESJH009-03, is being recalled by AVID Medical, Inc.
The reason given in the enforcement record is the potential for an incomplete seal on the header bag.
The record lists 240 units carrying UDI-DI 10809160427316, from lot 1653112 with an expiration of 5/28/2028. Distribution was in Georgia, Illinois, Nebraska and Maryland. The FDA has classified the action as Class II.
An incomplete seal on the packaging affects the sterile barrier of a procedure pack. The enforcement record reports no injuries. Facilities should quarantine the affected lot and follow the firm's instructions.
The recalled product
- Product
- Halyard, EP LAB PK. Catalog Number: ESJH009-03.
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Procedure tray
- Affected units
- 240
Distribution
Part of a larger recall action
This product is one of 5 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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