Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tr

FDA device recall Z-1611-2023 · posted 2023-05-18 · Open, Classified

Recall details

Recalling firm

TELEFLEX LLC

Reason for recall

The product contains an expired diluent vial. If the impacted product is used, the sterility of the diluent component cannot be assured as it has passed beyond the studied shelf life of the product.

Action taken

Teleflex issued an URGENT - MEDICAL DEVICE RECALL notice to its consignees on 04/12/2023 via FedEx 2nd day. The notice explained the issue and the hazard and requested the following actions be taken: Medical Facilities - immediately check your inventory for product within the scope of this recall. Users should cease use and distribution of affected product and immediately quarantine the affected product. If impacted product is on hand, mark the applicable checkbox on the Acknowledgement Form and fax it to 1-855-419-8507, including Attn: Customer Service or using the email address recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. Distributors were directed to immediately check your inventory for product within the scope of this recall. Users should cease use and distribution of affected product and immediately quarantine the affected product. They were further directed to notify their customers, collect the response forms, and upon completion of the action forward the completed Acknowledgement Form to recalls@teleflex.com.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MGB

Quantity affected

1140 units

Distribution

US Nationwide

Date initiated

2023-04-12

Date posted

2023-05-18

Location

Morrisville, NC