Medline C-Section Convenience Kits Recalled Due to Quality Issues in Bupivacaine Component
Medline Industries, LP is recalling specific C-Section convenience kits because they contain Bupivacaine Hydrochloride in Dextrose Injection, USP, which is subject to a voluntary recall due to quality issues.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this as a Class I recall, which is the highest level of severity.
Plain-English summary
Medline Industries, LP is recalling specific Medline C-Section convenience kits. These kits contain B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP.
The recall was initiated because the manufacturer of the Bupivacaine component, Huons Co, Ltd., issued a voluntary recall of the product due to quality issues. B. Braun Medical Inc. was notified of this recall by their supplier, Spectra Medical Devices, LLC.
This recall affects specific Medline SKU numbers: DYNJ910835 (Lot 25BBC541) and DYNJ910835A (Lot 25DBP805). Distribution has been identified in OH, CA, IL, IN, FL, SC, AZ, and NJ.
The recalled product
- Product
- MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU DYNJ910835A; medical convenience kits
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 56
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 (2)
- 2) Medline SKU DYNJ910835A: 10198459252570 (each) 40198459252571 (case)
- Kit Lot Number 25DBP805.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Medline Industries, LP 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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