Medline Convenience Kits Medical Devices Recalled for Quality Issues
Medline Industries is recalling four models of Convenience Kits containing Lidocaine and Bupivacaine injections due to quality issues identified 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: This recall is classified as FDA Class I, which triggers a minimum score of 4 per the rubric: "If the agency's own classification is FDA Class I or USDA Class I, never go below 4."
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits in four models: DRAWER 6A ADULT CENTRAL LINE (Model ACC010890), OPEN HEART A OVERHEAD (Model DYNJ910066), OPEN HEART (Model DYNJ9855016V), and OPEN HEART (Model DYNJ9855016X). These kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP.
The recall was initiated due to quality issues identified during a recent FDA inspection of the supplier. A total of 503 units have been distributed nationwide across the United States.
Customers who have received these products should stop use immediately and contact Medline Industries for instructions on return or disposal. The affected lot numbers are: 25BDA811, 25DDB415, 25DDC095 (Model ACC010890); 25ADB324, 25FDB473, 25GDA336, 24FDB427 (Model DYNJ910066); 25ABH622, 25CBA788, 25CBF665, 25DBR616, 25FBA415, 25HBT666 (Model DYNJ9855016V); and 25KBO109 (Model DYNJ9855016X).
The recalled product
- Product
- Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2) OPEN HEART A OVERHEAD, Model Number: DYNJ910066; 3) OPEN HEART, Model Number: DYNJ9855016V; 4) OPEN HEART, Model Number: DYNJ9855016X
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Hazard
- quality-defect
- supplier-inspection
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) ACC010890
- UDI-DI: 10198459139833(each)
- 40198459139834(case)
- Lot Number: 25BDA811
- 2) ACC010890
- Lot Number: 25DDB415
- 3) ACC010890
- Lot Number: 25DDC095
- 4) DYNJ910066
- UDI-DI: 10195327565596(each)
- 40195327565597(case)
- Lot Number: 25ADB324
- 5) DYNJ910066
- Lot Number: 25FDB473
- 6) DYNJ910066
- Lot Number: 25GDA336
- 7) DYNJ910066
- Lot Number: 24FDB427
- 8) DYNJ9855016V
- UDI-DI: 10198459019951(each)
Distribution
Distributed nationwide across the United States.
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