Medline pacemaker drape pack convenience kits recalled for seal defects
Medline is recalling its Custom Pacemaker Drape Pack (Model DYNJCD0339) due to potential weak or open seals on breather pouches used in sterile convenience kits.
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: This is a Class II recall for sterile medical device packaging with a potential defect that could compromise product sterility. The defect poses a theoretical risk of harm (loss of sterility assurance) for a high-risk product category (sterile implant/procedure kits), and no illnesses or injuries are reported in the source text.
Plain-English summary
Medline Industries, LP is recalling certain sterile convenience kits, specifically the Custom Pacemaker Drape Pack (Model Number DYNJCD0339, Lot Number 24KBK055), distributed worldwide including the US, Canada, Mexico, Panama, and the Virgin Islands.
The recall is being issued due to a potential for open or weak seals on purchased breather pouches used for packaging these sterile convenience kits. Compromised seals on sterile packaging could affect the sterility assurance of the contents.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAPE PACK, Model Number: DYNJCD0339
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- seal-defect
- sterility-compromise
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 (4)
- 1) DYNJCD0339
- UDI-DI: 10195327483753(each)
- 40195327483754(case)
- Lot Number: 24KBK055
Distribution
Distributed nationwide across the United States.
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