[Recalled] STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray — Medical and surgical procedure trays and kits underwent certain manufacturing c… | FDA 2022-11-02

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Stradis Medical, LLC dba Stradis Healthcare

• HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549, — Class II
• STRADIS HEALTHCARE, Angioplasty, Item No.682-1937, — Class II
• STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray — Class II
• HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089 — Class II
• STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1, — Class II
• HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482 — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.