HENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890

FDA device recall Z-0521-2023 · posted 2022-12-14 · Open, Classified

Recall details

Recalling firm

Stradis Medical, LLC dba Stradis Healthcare

Reason for recall

Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

Action taken

Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.

Root cause

Packaging process control

Status

Open, Classified

Product code

LRO

Quantity affected

25 units

Distribution

US nationwide distribution, and Canada.

Date initiated

2022-11-02

Date posted

2022-12-14

Location

Peachtree Corners, GA