Medline Suction Catheters Recalled for Sterilization Error
Medline Industries is recalling 120 units of sterile suction catheters that were distributed before being sterilized.
What this means for you
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 distributed without sterilization, creating a risk of infection or harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medline Industries Inc is recalling 120 units of MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHEAL TUBE, 12 Fr, REF DYNCSDS12. The recall was initiated because the products were labeled as sterile but were distributed prior to the sterilization process.
The affected units, identified by Lot 28617070015, were distributed to facilities in Florida, Indiana, Tennessee, Georgia, New Jersey, Utah, Maryland, Nicaragua, and Honduras. The source text does not specify the exact dates of distribution or the specific facilities involved.
Consumers and healthcare providers should stop using these products immediately. Medline Industries Inc is the recalling firm responsible for this action.
The recalled product
- Product
- MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHEAL TUBE, 12 Fr, REF DYNCSDS12, 1 Each, Sterile
- Manufacturer
- Medline Industries Inc
- Affected units
- 120
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 28617070015
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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