Medline Recalls Pediatric Anesthesia Circuits Due to Tubing Disconnection
Medline Industries is recalling 4,040 pediatric anesthesia circuits because the inspiratory tubing may be disconnected from the connector.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that poses a risk of harm to patients, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity rating.
Plain-English summary
Medline Industries Inc is recalling 4,040 units of Anesthesia Pediatric Circuit 72", Model DYNJAPF6057A. The recall covers Lots 19GBI659 and 19HBP065. The affected products were distributed to two consignees in Pennsylvania.
The recall was initiated because the 10mm inner green inspiratory tubing is disconnected from the tee connector at the machine end of the circuit. This defect could potentially affect the function of the anesthesia delivery system.
Healthcare facilities and consumers who have these specific model and lot numbers should stop using the products and contact Medline Industries for further instructions.
The recalled product
- Product
- Anesthesia Pediatric Circuit 72", Model DYNJAPF6057A
- Manufacturer
- Medline Industries Inc
- Affected units
- 4,040
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 (2)
- Product Model DYNJAPF6057A
- Lots 19GBI659 and 19HBP065
Distribution
Distributed in 1 state:
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