Medline Pediatric Suction Catheters Recalled for Sterilization Error
Medline Industries is recalling 190 units of pediatric elbow closed suction catheters because they were distributed before being sterilized.
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 that was not sterilized as labeled, creating a risk of infection. This fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries Inc is recalling 190 units of MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8. The recall was initiated because the products were labeled as sterile but were distributed prior to the sterilization process.
The affected units are identified by Lot 2861707008. These products were distributed to facilities in Florida, Indiana, Tennessee, Georgia, New Jersey, Utah, Maryland, Nicaragua, and Honduras.
Consumers and healthcare providers should stop using these specific units and contact Medline Industries for further instructions or a replacement.
The recalled product
- Product
- MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8
- Manufacturer
- Medline Industries Inc
- Affected units
- 190
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 (1)
- Lot 2861707008
Distribution
Part of a larger recall action
This product is one of 2 recalled by Medline Industries Inc 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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