Design Options spinal trays recalled over Huons bupivacaine quality issues
Design Options spinal needle anesthesia procedure kits are being recalled because they contain Bupivacaine Hydrochloride in Dextrose Injection subject to the Huons recall.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.
Plain-English summary
Design Options Spinal Tray spinal needle anesthesia procedure kits are being recalled, covering material numbers including 560074, 560214, 560272 and others listed in the recall notice. The action covers 104,720 units.
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection. The FDA classified the action as Class I, its most serious classification.
Distribution was nationwide in the United States. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected kits using the material numbers, UDI-DI codes and batch numbers in the recall notice, quarantine any stock on hand, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C 20061890 (560074), SSK S C H (560214), SSK BJC H S (ORIGINAL CUST) (560272), SSK CA P M C (ORIGINAL CUST) (560327), SSK T M H (560394), SSK S O 20070208…
- Manufacturer
- B Braun Medical Inc
- Affected units
- 104,720
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 (20)
- 1. Material: 560074
- UDI-DI Primary/Individual Unit of Use: 04046964317873/04046964317859
- Batch Numbers: 0061960383
- 0061972565
- 2. Material: 560214
- UDI-DI Primary/Individual Unit of Use: 04046964318061/04046964318054
- Batch Numbers: 0061971346
- 0061977782
- 3. Material: 560272
- UDI-DI Primary/Individual Unit of Use: 04046964318108/04046964318085
- Batch Numbers: 0061960367
- 0061971330
- 4. Material: 560327
- UDI-DI Primary/Individual Unit of Use: 04046964318221/04046964318207
- Batch Numbers: 0061960420
- 0061977751
- 5. Material: 560394
- UDI-DI Primary/Individual Unit of Use: 04046964318429/04046964318405
- Batch Numbers: 0061964747
- 0061976985
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by B Braun Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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