Z-1743-2025Class II

Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit

Name: Z-1743-2025 Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit
Creator: AVID Medical, Inc.
Published: 2025-03-31
License: https://open.fda.gov/license/

Avid Medical, Inc. a Medical Action Ind. Company 305 / initiated 2025-03-31 / Open, Classified / root cause: manufacturing process

FDA source

AVID Medical, Inc. began a recall of Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit on 2025-03-31. FDA classified it as Class II and gives the reason as "An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1743-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-31
Posted: 2025-05-09
Recalling firm: Avid Medical, Inc. a Medical Action Ind. Company 305
Product: Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.
Product code: OEZ Cardiovascular Procedure Kit
Reason for recall: An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An URGENT: MEDICAL DEVICE RECALL NOTIFICATION dated 3/31/25 was emailed to consignees. The notification indicates that this recall is due to Ethicon having recalled PDS II, PDS Plus, PROLENE, and ATHIBOND EXCEL sutures, which are components in the convenience kits being recalled by the recalling firm. Consignees are being instructed to discontinue use of the Johnson & Johnson Ethicon Sutures contained inside the recalled AVID kits identified in the recall notification and to add the provided labels to affected kits to ensure recalled sutures are discarded. Distributors are asked to forward the provided recall notification to their customers to which product was further distributed. Consignees are asked to return the provided response form via email. Questions regarding this recall event are to be directed to your distributor or sales representative.
Quantity in commerce: 72 units
Distribution: US Nationwide distribution in the states of IL & LA.
Product codes and lots: Model No. RPGH9472-01; UDI: 10809160211311; Lot Code: Lot: 1636640; Exp: 1/13/2028.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1743-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1741-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-21	2025-05-09
Z-1742-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-21	2025-05-09
Z-1743-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-21	2025-05-09

Product code OEZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)