Medline Convenience Kits containing anesthesia components recalled for quality issues
Medline Industries is recalling Medline Convenience Kits (models DYNJ905503F and DYNJ905503G) that contain Arrow Kits with 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: This is an FDA Class I recall of a medical device. The source confirms the recall involves injectable anesthetic components (Lidocaine and Bupivacaine), which are high-risk products used in clinical settings. Although no injuries or illnesses are reported in the source text, the agency's Class I classification mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits in two models (DYNJ905503F and DYNJ905503G), marketed as CV ANESTHESIA - ROOM SET UP kits. 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 227 units have been distributed nationwide.
Customers who have received these kits should discontinue use and contact Medline Industries, LP for instructions on return or destruction. Healthcare facilities should verify that they do not have affected units in their inventory, particularly those matching the lot numbers specified in the recall.
The recalled product
- Product
- Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP; 2) DYNJ905503G, Model Number: CV ANESTHESIA - ROOM SET UP
- Manufacturer
- Medline Industries, LP
- Hazard
- quality-defect
- injection-component-defect
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) DYNJ905503F
- UDI-DI: 10193489967272(each)
- 40193489967273(case)
- Lot Number: 24GBR740
- 2) DYNJ905503F
- Lot Number: 24JBP984
- 3) DYNJ905503G
- UDI-DI: 10198459200397(each)
- 40198459200398(case)
- Lot Number: 26DBJ110
- 4) DYNJ905503G
- Lot Number: 25ABJ069
- 5) DYNJ905503G
- Lot Number: 25ABL749
- 6) DYNJ905503G
- Lot Number: 25CBB762
- 7) DYNJ905503G
- Lot Number: 25DBG799
- 8) DYNJ905503G
- Lot Number: 25EBM994
Distribution
Distributed nationwide across the United States.
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