Medline Anterior Hip Kits Recalled Due to Quality Issues in Bupivacaine Injection
Medline Industries, LP is recalling specific Medline kits containing B. Braun convenience kits because they include Bupivacaine Hydrochloride in Dextrose Injection, USP, which has been recalled 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 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: The recall is classified as FDA Class I, which indicates a situation where there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Plain-English summary
Medline Industries, LP is recalling specific Medline Anterior Hip kits (SKU DYNJ909640G) that contain B. Braun convenience kits. These kits include Bupivacaine Hydrochloride in Dextrose Injection, USP.
The recall was initiated because the manufacturer of the Bupivacaine, Huons Co, Ltd., issued a voluntary recall of the injection due to quality issues. B. Braun Medical Inc. was notified of this recall by their supplier, Spectra Medical Devices, LLC.
This recall affects 60 kits distributed in OH, CA, IL, IN, FL, SC, AZ, and NJ. The affected kits include Lot Number 25DBF430.
The recalled product
- Product
- MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 60
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)
- UDI/DI 10198459280559 (each) 40198459280550 (case)
- Lot Number 25DBF430
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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