Recall record at a glance
| Official record | Z-0560-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Atrium Medical Corporation |
| Report date | Dec 12, 2018 |
| Recall initiation date | Oct 12, 2018 |
| Quantity | 2930 units |
| Location | Merrimack, NH, United States |
Official product description
Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
Why the product was 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.
Distribution information
Worldwide distribution - US Nationwide distribution, and country of Saudi Arabia.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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