Summary
The FDA issued a Class II for Atrium Pneumostat Chest Drain Valve, Part Number 16100 by Atrium Medical Corporation. Reason: The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm.
Details
Source
Device Recall
External ID
Z-2592-2021
Action Date
2021-10-06
Status
Ongoing
Category
device
Product Description
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Lot/Code Info: Lots 433297 433298 433974 433692 433693 434040 434962 435699 432585 435659 435660 436107 436106 437111 437530 438520 439396 439891 439905 440201 441182 441183 441392 441184 441185 441553 441554 443330 443362 443849 443968 445021 446022 447065 448203 447066 448138 448139 448618 448995 448996 450275 449702 449703 449992 449993 450659 450467 450923 450924 451439 452012 452013 453085 453472 452575 453404 454260 454344 454345 454803 454589 454850 455370 454851 455360 455359 455898 455900 455901 456447 456448 456904 456905 458298 458300 458299 458301 458642 458643 458644 458645 459216 461545 463439 463441 463469 463442 463443 463586 463587 464069 464103 464809 464104 464105 464669 465368
Quantity Affected: 92,430 units
Reason for Recall
The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.
Distribution
Domestic distribution nationwide. Foreign distribution worldwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-26
Company
Merrimack, NH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 201 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Atrium Medical Corporation has 88 FDA actions in our database, including 86 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Atrium Medical Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Atrium Medical Corporation have FDA actions?
Atrium Medical Corporation has 88 FDA actions in our database, including 86 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2592-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29