Recall record at a glance
| Official record | Z-1021-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | B. Braun Medical, Inc. |
| Report date | Feb 5, 2025 |
| Recall initiation date | Dec 4, 2024 |
| Quantity | 1090 units |
| Location | Allentown, PA, United States |
Official product description
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
Why the product was recalled
Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the required catheter connector and therefore is unable to be used to administer medication.
Distribution information
US Nationwide distribution in the states of MO, OK.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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