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U.S. Department of Health and Human Services

Class 2 Device Recall Oximeter

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  Class 2 Device Recall Oximeter see related information
Date Initiated by Firm October 11, 2007
Date Posted April 11, 2008
Recall Status1 Terminated 3 on December 18, 2011
Recall Number Z-0843-2008
Recall Event ID 45812
510(K)Number K002690  K050056  
Product Classification Pluse Oximeter - Product Code DQA
Product Nonin Model 2500 PalmSAT handheld pluse Oximeter , Nonin Medical, Inc., Plymouth, MN USA
Code Information 500222509 500207705 500222537 500222539 500222540 500222541 500222542 500222546 500222547 500222548 500222552 500222554 500222572 500222592 500222594 500222595 500207668 500207669 500207684 500222521 500222525 500218324 500218325 500218331 500218332 500218333 500218335 500218337 500218338 500218340 500218346 500222496 500222507 500218319 500218320 500207666 500218365 500218334 500218339 500218368 500218377 500218378 500222497 500222502 500222506 500222511 500222513 500207691 500207698 500207703 500207667 500222522 500222523 500207675 500207678 500207679 500207685 200207689 50207693 500207704 500222492 500222498 500222501 500222504 500222508 500222512 500222518 500222527 500222538 500222544 500222545 500222549 500222550 500222551 500222556 500222558 500222559 500222560 500222561 500222562 500222576 500222579 500222580 500222591 500222592 500222593 500207663 500207670 500207673 500207674 500207676 500207682 500207683 500207686 500207687 500207688 500218321 500218322 500218323 500218326 500218327 500218328 500218329 500218330 500218341 500222510 500207695 500207696 500207697 500207707 500207708 500222500 500222543 500222553 500222555 500222564 500222578 500222524 500222526 500218362 500218363 500218364 500218366 500218369 500218370 500218373 500218376 500222493 500222494 500222528 500222529 500222530 500222534 500222491 500222499 500222516 500222517 500207649 500207651 500207652 500207653 500207654 500207655 500207656 500207657 500207658 500207659 500207660 500207661 500207662 500207663 500207664 500207665 500207071 500207672 500207680 500207681 500218349 500218350 500218351 500218354 500218355 500218356 500218358 500218359 500218360 500218361 500218367 500218374 500222477 500222478 500222479 500222480 500222481 500222482 500222483 500222484 500222485 500222486 500222487 500222488 500222489 500222490 500222495 500222503 500222505 500222514 500222515 500222519 500222520 500222531 500222532 500222533 500222535 500222536 500222574 500222577 500222582 500222583 500222584 500222585 500222586 500222587 500222588 500222589 500222590 500222596 500207677 500207692 500207694 500207699 500207700 500207701 500207690 500207702 500218336 500218342 500218343 500218344 500218345 500218347 500218348 500218352 500218353 500218357 500218370 500218372 500218375 500222557 500222563 500222565 500222566 500222567 500222568 500222569 500222570 500222571 500222573 500222575 500222581 
Recalling Firm/
Manufacturer		 Nonin Medical, Inc
13700 1st Ave N
Plymouth MN 55441-4595
For Additional Information Contact
763-553-9968
Manufacturer Reason
for Recall		 Incorrect Label: The label on the back of the device may show Model 2500A rather than Model 2500.
FDA Determined
Cause 2		 Error in labeling
Action An Urgen Field Action letters was sent (10/11/07) to Nonin distributors who received the potentially mislabeled product. The letters provided labeling differences and included instructions for notifying their customers, with a response form to be returned to Nonin. For additional information please contact Kim Aves at 763-577-3196.
Quantity in Commerce 240
Distribution Worldwide Distribution ---- USA including states of ME, SC, SD, CA, MO, NY, MI, FL, IL, PA, NC, CT, and TX, and countries of Canada, Greece, Russia, Italy, Sweden, Australia, & Japan.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQA and Original Applicant = NONIN MEDICAL, INC.
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