—#213484

Product

Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.

FDA product code: OEZ — Cardiovascular Procedure Kit
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Model No. RPGH9472-01; UDI: 10809160211311; Lot Code: Lot: 1636640; Exp: 1/13/2028.

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: AVID Medical, Inc.
Address: 9000 Westmont Dr, Toano, Virginia 23168-9351

Distribution

Distribution pattern: US Nationwide distribution in the states of IL & LA.

Timeline

Recall initiated: 2025-03-31
Posted by FDA: 2025-05-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213484. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.