Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE recall: Sterility Concern
Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
Why was Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE recalled?
This recall has been initiated in response to a seal defect found in certain sterile barrier pouches containing the device. Affected pouches are un-sealed at the bottom. If the pouch defect is not detected it could represent a serious hazard to the patient. A sterility breach could potentially lead to product contamination. The potentially affected device is used in contact with critical anatomical structures and deep into the body. If contaminated, the consequences for the patient could be severe. The severity of the possible clinical complications depends on the degree of contamination of the device, the microorganisms involved and the patient s risk factors. To date, Getinge/Atrium has not received any reports of patient injury related to this issue.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
ME221275
- Product
- Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
- Recalling firm
- Atrium Medical Corporation
- Quantity
- 2930 units
- Distribution
- Worldwide distribution - US Nationwide distribution, and country of Saudi Arabia.
- Recall date
- December 12, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)