[Recalled] HYDRATOME RX 44-20MM/450CM Material Number: M00583060 — Sterility of device is compromised due to a sterile barrier breach | FDA 2021-12-22

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Sterility of device is compromised due to a sterile barrier breach

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 Boston Scientific Corporation

• VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract. — Class II
• EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ultrasonic Core, and a reusable Control Unit 4.0. The device delivers the physician-specified fluids and ultrasound to the intravascular treatment site. The r — Class II
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter — Class I
• PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231). — Class I
• Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331 — Class II
• Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology) — 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.