Z-2592-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 6, 2021
- Initiation Date
- August 26, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 92,430 units
Product Description
Atrium Pneumostat Chest Drain Valve, Part Number 16100
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 Pattern
Domestic distribution nationwide. Foreign distribution worldwide.
Code Information
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