Medline Convenience Kits with Central Line Insertion recalled for quality issues
Medline Industries is recalling two models of Convenience Kits (ACC011142 and DYNJ8407) distributed nationwide. The kits contain injectable anesthetics that were recalled 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 used in sterile procedures (central/arterial line insertion). FDA Class I recalls are classified as Severe (score 4) per the rubric, as they involve devices where there is a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits, which are central and arterial line insertion kits. The affected models are: 1) DRAWER 6 CENTRAL LINE INSERTION kit (Model ACC011142, Lot Numbers 26DDA462 and 26DDA547), and 2) CENTRAL AND ARTERIAL LINE TOTE (Model DYNJ8407, Lot Number 26DBB599). A total of 233 units were 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 due to quality issues identified during a recent FDA inspection of the supplier.
Healthcare providers and facilities that have received these kits should stop using them immediately and contact Medline Industries, LP for instructions on return or replacement.
The recalled product
- Product
- Medline Convenience Kits: 1) DRAWER 6 CENTRAL LINE INSERTIO, Model Number: ACC011142; 2) CENTRAL AND ARTERIAL LINE TOTE, Model Number: DYNJ8407
- Manufacturer
- Medline Industries, LP
- Hazard
- quality-defect
- injectable-pharmaceutical
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 (10)
- 1) ACC011142
- UDI-DI: 10198459721342(each)
- 40198459721343(case)
- Lot Number: 26DDA462
- 2) ACC011142
- Lot Number: 26DDA547
- 3) DYNJ8407
- UDI-DI: 10198459704543(each)
- 40198459704544(case)
- Lot Number: 26DBB599
Distribution
Distributed nationwide across the United States.
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