Medline Pediatric EP Pack Procedural Kits with Sterile Ultrasound Gel Defect
Medline is recalling pediatric electrophysiology procedural kits because the ultrasound gel component may not meet sterility specifications. The recall affects 192 kits distributed worldwide from April 2020 to April 2023.
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: FDA Class II recall with a theoretical hazard (potential failure to meet sterility specifications) and no reported illnesses or injuries. Medical device used in sterile procedures presents risk of harm, but no actual patient harm has been documented.
Plain-English summary
Medline Industries is recalling Custom Sterile and Non-Sterile Procedural Kits labeled as PEDIATRIC EP PACK (Model Number DYNJ45158A) that contain Turkuaz Ultrasound Gel. The ultrasound gel component in these kits may not meet sterility specifications, which could compromise the sterile conditions required for pediatric electrophysiology procedures.
This recall affects 192 kits with Model Number DYNJ45158A and UPC Number 088827750721, with all lot numbers distributed between April 1, 2020, and April 28, 2023. The affected kits were distributed worldwide to the United States and internationally to Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates.
No illnesses or injuries related to this recall have been reported.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model Number: DYNJ45158A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterility-defect
- contamination-risk
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 (3)
- Model Number: DYNJ45158A
- UPC Number: 088827750721
- all lot numbers distributed from Medline between 04/01/2020 and 04/28/2023.
Distribution
Distributed nationwide across the United States.
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