Medline Orthopedic Surgery Kits Recalled Over Bupivacaine Quality Issue
Medline Industries, LP is recalling 2301 convenience kits used in orthopedic joint procedures because they contain B. Braun kits with Bupivacaine Hydrochloride in Dextrose Injection, USP, which the manufacturer Huons Co, Ltd. voluntarily 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 per the rubric requires a severity score of at least 4 (Severe). Class I recalls are those where there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences.
Plain-English summary
Medline Industries, LP is recalling specific Medline convenience kits that contain B. Braun convenience kits, which include Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall was initiated after B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC, that Huons Co, Ltd., the manufacturer of the Bupivacaine product, had issued a voluntary recall due to quality issues.
The recalled Medline kits are used in total joint, total knee, and total hip procedures, including anterior and posterior hip approaches. The affected kits include 25 distinct Medline Kit SKUs, each associated with specific lot numbers and UDI/DI codes. A total of 2301 kits are included in the recall.
The recall affects products distributed across the United States, specifically to the following states: Ohio, California, Illinois, Indiana, Florida, South Carolina, Arizona, and New Jersey.
Healthcare facilities and distributors that received the affected kits should immediately quarantine and discontinue use of the recalled products. For questions or to arrange return or replacement, contact Medline Industries, LP using the contact information provided in the official recall notice.
The recalled product
- Product
- MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A; 2) TOTAL KNEE BASIC, Medline Kit SKU DYNJ902378J; 3) TOTAL HIP, Medline Kit SKU DYNJ903492K; 4) ANTERIOR HIP, Medline Kit SKU DYNJ903493I; 5) ANTERIOR HIP, Medline Kit SKU DYNJ903493J…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 2,301
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)
- Medline Kit SKU DYKS1574A
- UDI/DI 10198459147449 (each) 40198459147440 (case)
- Kit Lot Number 25ELB079
- Kit Lot Number 25DLA930
- Medline Kit SKU DYNJ902378J
- UDI/DI 10198459128813 (each) 40198459128814 (case)
- Kit Lot Number 25IBN992
- Kit Lot Number 25HBS205
- Kit Lot Number 25DBH984
- Kit Lot Number 25CBB436
- Kit Lot Number 25ABR220
- Kit Lot Number 24LBI991
- Medline Kit SKU DYNJ903492K
- UDI/DI 10198459255199 (each) 40198459255190 (case)
- Kit Lot Number 25CBR847
- Kit Lot Number 25CBE741
- Medline Kit SKU DYNJ903493I
- UDI/DI 10195327565510 (each) 40195327565511 (case)
- Kit Lot Number 25ADA380
- Kit Lot Number 24KDA993
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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