B Braun Medical has an active recall of the PERIFIX FX Continuous Epidural Anesthesia Tray nationwide. The recall cites a potential mispositioned catheter connector lid. Healthcare providers and patients should stop using the device and follow manufacturer instructions.
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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This is a sterile medical device used for continuous epidural anesthesia. It includes an epidural needle and catheter within a tray setup for clinical use.
A lid misalignment could compromise catheter connector integrity, potentially impacting sterile connection and delivery.
This recall is not described as part of a broader industry-wide pattern in the provided data.
Immediate discontinuation of use is required. No injuries reported yet, but potential for device malfunction requires medical oversight.
Identifier labels are on the tray and packaging; UDI and lot numbers are printed on the labeling and unit packaging.
Refunds or replacements follow manufacturer instructions via notification letters; timelines not specified.
Keep recall notices, product packaging, lot numbers, and correspondence with supplier.
Brand: B BRAUN MEDICAL. Product: PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. Tuohy Epidural Needle Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code CE17TKFCPS. Model references include REF: 332078, UDI-DI primary 04046955899432 and Unit of Use 04046955899449. Lot numbers include 0062006314, 0062011670, 0062028428. Distribution: Nationwide across 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.
No injuries or incidents have been reported in the provided data.
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