Bard Access Systems, Inc. — Class II: CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566
Bard Access Systems, Inc. is recalling specific Poly Midline Catheter kits due to lidocaine ampoules manufactured under deficient practices by a third-party supplier. The recall is currently ongoing and affects both single-lumen 4 Fr models.
Bard Access Systems, Inc., healthcare providers using Poly Per-Q-Cath Midline catheters, and quality/regulatory personnel managing combination device kits containing anesthetic components.
This recall highlights the regulatory risks associated with convenience kits that include drug components. Deficiencies at a drug supplier's facility can necessitate a recall of the entire medical device system if the components are integrated. It underscores the importance of stringent supplier oversight and the potential for secondary market actions when primary pharmaceutical suppliers face GMP compliance issues.
Identify and quarantine affected midline catheter kits containing the recalled lidocaine ampoules. Review supplier quality agreements and incoming material inspection protocols for drug components packaged within device kits. Regulatory teams should evaluate the impact on current inventory and prepare necessary field safety notices.
Class II. Reason: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.. Product: CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 The Poly Per-Q-Cath Midline catheters are indicated for short or long term peripheral access to the peripheral venous system for selected intravenous therapies and blood sarnpling.. Firm: Bard Access Systems, Inc. (Salt Lake City UT United States). Status: Ongoing.
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