PICC Kit Recall: Outer Bag Pinhole Leaks May Compromise Sterility
Stradis Healthcare is recalling PICC Kits due to potential pinhole leaks in the outer bag that may compromise kit sterility. No illnesses or injuries have been reported.
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 medical device recall involving potential sterility breach of PICC kits with no reported illnesses or injuries. The hazard is theoretical (pinhole leaks may compromise sterility), meeting the criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Stradis Healthcare is recalling PICC (Peripherally Inserted Central Catheter) Kits in response to an FDA Class II notice. The kits may have pinhole leaks in the outer packaging near the seal, which could compromise the sterility of the product.
The recall affects PICC Kits with Assembly Number ACC-2550, UDI-DI: M752ACC25501, and Lot Number 220241506. A total of 180 units were distributed nationwide across Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas, and Washington.
No illnesses or injuries have been reported. Affected customers and healthcare facilities should check their supplies for the recalled lot number and contact Stradis Healthcare for instructions on handling the affected kits.
The recalled product
- Product
- PICC KIT, 10/CS, ACCESS MEDICAL LABEL
- Manufacturer
- Stradis Healthcare
- Hazard
- sterility-breach
- packaging-integrity
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)
- Assembly Number ACC-2550
- UDI-DI: M752ACC25501
- Lot Number: 220241506
Distribution
Distributed nationwide across the United States.
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