Recall archive / FDA company announcement
Atrium: Express Drains — FDA announcement Jan 4, 2024
Published notice; closure not supplied
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date Jan 4, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Express Drains
- Reason
- Syringes provided with Express Drains could not be verified to be sterile.
- Classification
- Not supplied
- Recalling firm
- Getinge/Atrium Medical Corporation
- Quantity
- Not supplied
- Agency-reported status
- Company recall announcement
- Source record identifier
- 66bba6fc135fc849
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Affected lot numbers:; Please examine your inventory immediately to determine if you have any of the Atrium Express Dry Suction Dry Seal Chest Drains with the REF and LOT numbers listed in this notice.; Should you have any affected product, please forward this notification to the clinical area(s) of your facility where this product may be used/stored. The LOT Number (6 digit code) can be found on the product label (illustrated in Figures 1 and 2 below.); Whether or not you have affected product(s) with the REF and LOT numbers listed in this notice, please complete and sign the attached MEDICAL DEVICE – CORRECTION RESPONSE FORM provided with the notification to acknowledge that you have received this notification. Return the completed form to Getinge by e-mailing a scanned copy to [email protected] or by faxing the form to 1-866-409-8277. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
The affected products were manufactured from November 20, 2020, to September 5, 2023, and distributed from December 18, 2020, through November 8, 2023.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Fda listing date
- Jan 4, 2024
- Company announcement date
- Jan 3, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.