Medline Medical Procedure Convenience Kits Recalled Due to Potential Drug Ineffectiveness
Medline Industries, LP is recalling certain MEDLINE medical procedure convenience kits because they contain ICU Medical, Inc. pain management kits that may be ineffective.
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 FDA has classified this as a Class I recall, which is the most serious classification, and the hazard involves potential drug ineffectiveness.
Plain-English summary
Medline Industries, LP is recalling 52 MEDLINE medical procedure convenience kits (SKU CDS984556N) labeled as HIP CDS-LF. These kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP.
The recall was initiated due to quality issues that could result in the drug being ineffective.
This recall affects kits distributed in Missouri, Colorado, and Illinois. Affected kits include UDI/DI 10198459266621 and 40198459266622, with lot numbers 26EDA285, 26DDA718, 26BDB740, 26ADB079, 26ADA161, 25KDB472, and 25GDA213.
The recalled product
- Product
- MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 52
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 (8)
- UDI/DI 10198459266621 (each) 40198459266622 (case)
- Lot Numbers: 26EDA285
- 26DDA718
- 26BDB740
- 26ADB079
- 26ADA161
- 25KDB472
- 25GDA213.
Distribution
Part of a larger recall action
This product is one of 2 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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