Epidural Tray Kits Recalled for Wrong Connector Type
B. Braun Medical recalls 3,890 PERIFIX epidural trays nationwide due to filter straws with incompatible neuraxial connectors instead of standard Luer connectors.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving a manufacturing defect in epidural administration equipment. The connector incompatibility prevents proper assembly and use of the kit, creating a risk of medication administration failure in a critical pain management procedure.
Plain-English summary
B. Braun Medical, Inc. is recalling 3,890 units of PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy epidural tray kits (Lot Number 0061855122, expiring October 25, 2024) distributed nationwide. The epidural tray kit is used for administering anesthetic or analgesic agents to the epidural space for pain management.
The recalled kits contain filter straws with neuraxial connectors. However, the filter straws should have standard Luer connections. Because of this mismatch, the filter straws cannot properly interface with the other components of the kit, preventing proper assembly and use.
Healthcare facilities and providers who received these kits should stop using them and contact B. Braun Medical for instructions on returning or replacing the affected units.
The recalled product
- Product
- Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of devices intended for the administration of an analgesic or anesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anestheti
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- connector-incompatibility
- assembly-defect
- medication-delivery-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 04046964178689 Lot Number: 0061855122 Exp. Date: 25.OCT.2024
Distribution
Distributed nationwide across the United States.
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