Medline Convenience Kits with Lidocaine and Bupivacaine Injections Recalled
Medline Industries is recalling 22 models of Convenience Kits that contain Lidocaine Hydrochloride Injection and Bupivacaine Hydrochloride in Dextrose Injection due to quality issues found during an FDA inspection of the supplier.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall. Per the rubric, FDA Class I recalls score at least 4, and this is classified as Severe because it involves pharmaceutical products with identified quality defects affecting injectable medications used in medical procedures.
Plain-English summary
Medline Industries, LP is recalling multiple models of Medline Convenience Kits distributed nationwide. These kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall was initiated because quality issues were identified during a recent FDA inspection of the supplier.
A total of 6,775 units are affected across 22 product models with multiple lot numbers. The products were distributed throughout the United States.
Consumers and healthcare facilities that have received affected kits should immediately cease use and contact Medline Industries, LP for instructions on return or disposal. Healthcare providers should review patient records to identify any patients who may have received these medications from recalled kits.
The recalled product
- Product
- Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART, Model Number: CDS840150W; 3) OPEN HEART ADULT, Model Number: CDS840396AA; 4) CABG A CDS, Model Number: CDS982269N; 5) OPEN HEART ANESTHESIA PACK, Model Number: CDS983849G; 6) OPEN HE
- Manufacturer
- Medline Industries, LP
- Affected units
- 6,775
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) CDS840144Q
- UDI-DI: 10195327263102(each)
- 40195327263103(case)
- Lot Number: 24LBH805
- 2) CDS840144Q
- Lot Number: 24HBM100
- 3) CDS840144Q
- Lot Number: 25ABR195
- 4) CDS840144Q
- Lot Number: 25EBS810
- 5) CDS840144Q
- Lot Number: 25FBS936
- 6) CDS840144Q
- Lot Number: 25GBX096
- 7) CDS840144Q
- Lot Number: 25IBT859
- 8) CDS840144Q
- Lot Number: 24KBE879
- 9) CDS840144R
- UDI-DI: 10198459561627(each)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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