Design Options Combined Spinal/Epidural Tray Recalled for Connector Defect
B. Braun Medical is recalling 1,090 units of the Design Options Combined Spinal/Epidural Tray due to an incorrect catheter connector that cannot securely connect to the epidural catheter, preventing medication administration.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is a Class II medical device with a structural defect preventing the critical function of medication administration. No illnesses or injuries have been reported, but the defect poses a risk to patients unable to receive necessary epidural anesthesia or analgesia, qualifying as a risk-of-harm product.
Plain-English summary
B. Braun Medical, Inc. is recalling 1,090 units of the Design Options Combined Spinal/Epidural Tray (Model 530159) due to a manufacturing defect. The kit contains an incorrect catheter connector that is smaller than the required size.
The incorrect connector cannot securely attach to the epidural catheter, making it impossible to use the tray to deliver pain medication to the intrathecal or epidural space. This functional defect prevents the medical device from being used as intended for pain control.
The affected units were distributed nationwide, with identified distribution in Missouri and Oklahoma. The recalled lot number is 0061916572.
Hospitals and healthcare facilities that received this product should stop using the affected units immediately. Contact B. Braun Medical, Inc. for instructions on product return or replacement.
The recalled product
- Product
- Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural space for pain control. Model/Catalog Number: 530159
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 1,090
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 (3)
- UDI-DI 04046964669286 (Primary)
- 04046964669279 (Unit of Use)
- Lot Number 0061916572
Distribution
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