Medline Pacemaker Drape Packs Recalled for Compromised Packaging Seals
Medline is recalling pacemaker drape packs due to potential open or weak seals on packaging breather pouches. The affected sterile kits were distributed worldwide including the United States, Canada, Mexico, Panama, and the U.S. Virgin Islands.
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 involving sterile medical device packaging with potential for compromised sterility. This is a risk-of-harm product where packaging integrity is critical; however, no illnesses or injuries have been reported, placing this in the High category per the rubric.
Plain-English summary
Medline Industries is recalling select Convenience Pacemaker Drape Packs (Model DYNJCD0339, Lot 24KBK055) due to a potential for open or weak seals on the breather pouches used for packaging these sterile kits.
The affected products were distributed worldwide, including throughout the United States, Canada, Mexico, Panama, and the U.S. Virgin Islands. The kits are used in various surgical procedures, particularly pacemaker implantation.
Open or weak seals can compromise the sterility of the products during storage and transport, potentially increasing the risk of microbial contamination. No illnesses or injuries have been reported to date.
Healthcare facilities should check their inventory for products with Lot Number 24KBK055 and contact Medline or their distributor for instructions on return, replacement, or disposal of the affected kits.
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
- packaging-defect
- contamination-risk
- weak-seal
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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