B Braun Medical recalled 21,270 PERIFIX FX Continuous Epidural Anesthesia Tray units distributed nationwide to hospitals and surgical centers after a lid-position defect was identified in the catheter connector. The defect allows the catheter connector lid to be in the incorrect position. Healthcare facilities and clinicians should stop using the device immediately and follow the manufacturer’s or
Potential for the lid of the catheter connector to be in the incorrect position.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B BRAUN MEDICAL INC or your healthcare provider for instructions. Notification method: Letter
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The PERIFIX FX Continuous Epidural Anesthesia Tray is used in surgical settings to administer epidural anesthesia via a Tuohy needle and associated catheter. It is distributed to healthcare facilities nationwide.
A potential misalignment of the catheter connector lid could compromise the integrity of the connection, potentially affecting safety during epidural administration.
This recall is not indicated as part of a broader industry pattern in the provided data.
Clinicians must verify device integrity before use. The issue prompts immediate removal from service to protect patients during anesthesia and may cause operational delays in procedures.
FDA recall page and manufacturer recall notice for instructions and disposition of units.
Refunds or replacements, if applicable, typically follow the manufacturer's timeline in 4-8 weeks depending on disposition and facility processing.
Keep a log of lot numbers checked, actions taken, communications with the manufacturer, and any refunds or replacements processed.
Model numbers and identifiers: REF: 332097; Product Code: CE17TKFCS; UDI-DI Primary: 04046955899470; UDI-DI Unit of Use: 04046955899487; Lot Numbers: 0062013051, 0062010532, 0062010533, 0062010534, 0062010535, 0062010536, 0062010555, 0062013050, 0062013053, 0062013052. Distribution: Nationwide to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. Sold since: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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