Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Express Mini 500 Dry Seal Chest Drain, Part Number 16400
Why it was recalled
The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
UDI-DI: 00650862164008; All lots manufactured 3 years prior to correction initiation: Lot Numbers: 477059 478375 481999 483536 484044 485782 486195 477059 478375 481105 485782 449700 450921 451436 460632 463584 463585 464668 472965 472969 473749 477059 445024 448992 449700 449990 450921 450922 451436 452010 452011 452574 453402 460620 460621 460629 460630 460631 460632 460633 460787 461043 461333 461336 461337 461821 461822 461823 461824 461940 462215 462487 462489 463584 463585 464101 464102 464667 464668 465132 465138 465516 465517 465667 465668 472838 472965 472966 472969 473749 475492 477059 477985 475492 477059 478375 481105 481998 482573 485782 486195 486195 474692 475492 477059 478375 480643 481104 481105 481998 481999 482001 482572 482573 483028 483536 484044 485782 486195 487568 487569 487570 488316 489338 489879 489880 490140 486195 487570 490140 472838 472965 472966 472968 472969 473221 473749 474692 475491 475492 477059 477926 477983 477984 477985 478374 479256 479870 480216 480217 480641 480642 480643
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Colombia, Czech Republic, Germany, Ecuador, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Indonesia, Ireland, Israel, Iceland, Italy, Jordan, South Korea, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Poland, Portugal, Sweden, Singapore, Slovenia, Thailand.
Recall record
- Recalling firm
- Atrium Medical Corporation
- Product type
- Devices
- Recall number
- Z-1303-2023
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Merrimack, NH
- Recall initiated
- 2023-03-01
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1303-2023 · Source: openFDA enforcement.