Events

Recall of Device Recall Pnemosure Insufflators

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Endoscopy.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    50777
  • Event Risk Class
    Class 2
  • Event Number
    Z-1198-2010
  • Event Initiated Date
    2008-12-29
  • Event Date Posted
    2010-03-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77163
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Carbon Dioxide Insuffiator for Laparoscopy and Endoscopic Vessel Harvesting - Product Code HIF
  • Reason
    Unexpected powering down/failure to boot up: a problem with a transistor in the heater/temperature sensor component in the device may cause the device to power off during surgery or to fail to boot up at all. the risk includes delay and interruption of ongoing surgical procedures.
  • Action
    Recall initiated 12/29/2009. Sales representatives were notified via phone and e-mail, while product advisory notices were sent to consignees via FedEx. Consignees are provided with a response form, and are instructed to run a software correction.

Device

Device Recall Pnemosure Insufflators
  • Model / Serial
    All products manufactured between April 2008 and December 2008. Listing Number E228526, serial lot numbers 0804CE398. 0804CE412 0804CE425 0804CE428 0804CE431 0804CE502 0804CE543 0804CE595 0804CE598 0804CE654 0805CE128 0805CE361 0805CE363 0806CE234 0806CE434 0806CE511 0806CE513 0806CE551 0807CE048 0807CE083 0807CE206 0807CE207 0807CE208 0807CE221 0807CE227 0807CE412 0807CE569 0807CE577 0807CE620 0807CE689 0807CE693 0807CE694 0807CE699 0807CE700 0807CE701 0807CE702 0807CE703 0807CE783 0808CE066 0808CE067 0808CE089 0808CE103 0808CE106 0808CE107 0808CE157 0808CE158 0808CE160 0808CE168 0808CE234 0808CE281 0808CE432 0808CE503 0808CE508 0808CE511 0808CE548 0808CE563 0808CE564 0808CE565 0808CE566 0808CE567 0808CE568 0808CE570 0808CE597 0808CE598 0808CE647 0808CE648 0809CE117 0809CE120 0809CE165 0809CE168 0809CE218 0809CE247 0809CE292 0809CE293 0809CE295 0809CE296 0809CE297 0809CE298 0809CE299 0809CE300 0809CE397 0809CE398 0809CE399 0809CE400 0809CE401 0809CE402 0809CE403 0809CE404 0809CE405 0809CE406 0809CE434 0809CE435 0809CE436 0809CE437 0809CE438 0809CE439 0809CE440 0809CE442 0809CE443 0809CE455 0809CE456 0809CE457 0809CE458 0809CE459 0809CE460 0809CE461 0809CE462 0809CE463 0809CE464 0809CE527 0809CE528 0809CE529 0809CE530 0810CE022 0810CE055 0810CE063 0810CE135 0810CE181 0810CE182 0810CE183 0810CE184 0810CE185 0810CE186 0810CE187 0810CE189 0810CE190 0810CE192 0810CE193 0810CE194 0810CE195 0810CE214 0810CE215 0810CE216 0810CE218 0804CE549 0804CE677 0805CE151 0806CE457 0806CE458 0806CE478 0806CE503 0806CE509 0806CE517 0806CE519 0806CE585 0807CE318 0807CE324 0807CE380 0807CE383 0807CE498 0807CE500 0807CE501 0807CE538 0807CE560 0807CE623 0807CE625 0807CE626 0807CE636 0807CE640 0807CE641 0807CE643 0807CE644 0807CE775 0807CE784 0808CE204 0808CE206 0808CE211 0808CE233 0808CE236 0808CE239 0808CE241 0809CE112 0809CE113 0809CE114 0809CE115 0804CE394 0804CE395 0804CE396 0804CE397 0804CE399 0804CE400 0804CE401 0804CE402 0804CE403 0804CE404 0804CE405 0804CE406 0804CE407 0804CE408 0804CE409 0804CE410 0804CE411 0804CE413 0804CE424 0804CE426 0804CE427 0804CE429 0804CE430 0804CE432 0804CE433 0804CE483 0804CE484 0804CE485 0804CE486 0804CE487 0804CE488 0804CE489 0804CE490 0804CE491 0804CE492 0804CE493 0804CE494 0804CE495 0804CE496 0804CE497 0804CE498 0804CE499 0804CE500 0804CE501 0804CE541 0804CE542 0804CE544 0804CE545 0804CE546 0804CE547 0804CE548 0804CE550 0804CE572 0804CE573 0804CE574 0804CE575 0804CE576 0804CE577 0804CE578 0804CE579 0804CE580 0804CE581 0804CE593 0804CE594 0804CE596 0804CE597 0804CE599 0804CE600 0804CE601 0804CE602 0804CE615 0804CE616 0804CE617 0804CE618 0804CE619 0804CE620 0804CE621 0804CE622 0804CE623 0804CE624 0804CE651 0804CE652 0804CE652 0804CE655 0804CE656 0804CE657 0804CE658 0804CE659 0804CE660 0804CE661 0804CE662 0804CE663 0804CE664 0804CE665 0804CE666 0804CE667 0804CE668 0804CE669 0804CE670 0804CE673 0804CE674 0804CE675 0804CE676 0804CE678 0804CE679 0804CE680 0804CE681 0804CE682 0804CE685 0804CE686 0804CE687 0804CE688 0804CE689 0804CE690 0804CE691 0804CE692 0804CE693 0804CE694 0804CE708 0804CE709 0804CE710 0804CE711 0804CE712 0804CE713 0804CE714 0804CE715 0804CE716 0804CE717 0804CE725 0804CE726 0804CE727 0804CE728 0804CE729 0804CE730 0804CE731 0804CE732 0804CE733 0804CE734 0805CE027 0805CE028 0805CE029 0805CE030 0805CE031 0805CE032 0805CE033 0805CE034 0805CE035 0805CE036 0805CE100 0805CE101 0805CE127 0805CE129 0805CE130 0805CE131 0805CE132 0805CE133 0805CE134 0805CE135 0805CE136 0805CE147 0805CE148 0805CE149 0805CE150 0805CE152 0805CE153 0805CE154 0805CE155 0805CE156 0805CE199 0805CE200 0805CE201 0805CE202 0805CE203 0805CE204 0805CE205 0805CE206 0805CE207 0805CE208 0805CE262 0805CE263 0805CE264 0805CE265 0805CE266 0805CE267 0805CE268 0805CE269 0805CE270 0805CE271 0805CE278 0805CE279 0805CE280 0805CE281 0805CE282 0805CE283 0805CE284 0805CE285 0805CE286 0805CE287 0805CE320 0805CE321 0805CE322 0805CE323 0805CE324 0805CE325 0805CE326 0805CE327 0805CE328 0805CE329 0805CE359 0805CE360 0805CE362 0805CE364 0806CE231 0806CE232 0806CE233 0806CE235 0806CE236 0806CE237 0806CE238 0806CE239 0806CE240 0806CE251 0806CE252 0806CE253 0806CE254 0806CE255 0806CE255 0806CE256 0806CE257 0806CE258 0806CE259 0806CE260 0806CE277 0806CE278 0806CE279 0806CE280 0806CE281 0806CE282 0806CE283 0806CE284 0806CE285 0806CE286 0806CE422 0806CE423 0806CE424 0806CE425 0806CE426 0806CE427 0806CE428 0806CE429 0806CE430 0806CE431 0806CE432 0806CE433 0806CE435 0806CE436 0806CE437 0806CE448 0806CE449 0806CE450 0806CE451 0806CE452 0806CE453 0806CE454 0806CE455 0806CE456 0806CE459 0806CE460 0806CE461 0806CE462 0806CE463 0806CE464 0806CE465 0806CE466 0806CE467 0806CE468 0806CE469 0806CE470 0806CE471 0806CE472 0806CE473 0806CE474 0806CE475 0806CE476 0806CE477 0806CE479 0806CE480 0806CE481 0806CE482 0806CE483 0806CE484 0806CE485 0806CE502 0806CE504 0806CE505 0806CE506 0806CE507 0806CE508 0806CE510 0806CE512 0806CE514 0806CE515 0806CE516 0806CE518 0806CE520 0806CE521 0806CE522 0806CE523 0806CE524 0806CE525 0806CE536 0806CE537 0806CE542 0806CE543 0806CE544 0806CE545 0806CE546 0806CE547 0806CE548 0806CE549 0806CE550 0806CE552 0806CE553 0806CE554 0806CE555 0806CE556 0806CE557 0806CE558 0806CE559 0806CE586 0806CE587 0806CE588 0806CE589 0806CE590 0806CE591 0806CE592 0806CE593 0806CE594 0806CE595 0806CE596 0806CE597 0806CE598 0806CE599 0806CE600 0806CE601 0806CE602 0806CE603 0806CE604 0807CE043 0807CE044 0807CE045 0807CE046 0807CE047 0807CE049 0807CE050 0807CE051 0807CE052 0807CE063 0807CE063 0807CE064 0807CE065 0807CE066 0807CE067 0807CE068 0807CE082 0807CE084 0807CE085 0807CE087 0807CE088 0807CE089 0807CE127 0807CE128 0807CE130 0807CE134 0807CE209 0807CE220 0807CE222 0807CE223 0807CE224 0807CE225 0807CE226 0807CE227 0807CE228 0807CE229 0807CE251 0807CE252 0807CE253 0807CE254 0807CE255 0807CE256 0807CE257 0807CE258 0807CE259 0807CE260 0807CE317 0807CE319 0807CE320 0807CE321 0807CE322 0807CE323 0807CE325 0807CE326 0807CE367 0807CE368 0807CE369 0807CE370 0807CE371 0807CE372 0807CE373 0807CE374 0807CE375 0807CE376 0807CE377 0807CE378 0807CE379 0807CE381 0807CE382 0807CE384 0807CE385 0807CE386 0807CE413 0807CE414 0807CE415 0807CE416 0807CE417 0807CE418 0807CE419 0807CE420 0807CE421 0807CE494 0807CE495 0807CE496 0807CE497 0807CE498 0807CE499 0807CE500 0807CE501 0807CE502 0807CE503 0807CE535 0807CE536 0807CE537 0807CE538 0807CE539 0807CE540 0807CE541 0807CE542 0807CE543 0807CE544 0807CE557 0807CE558 0807CE559 0807CE561 0807CE562 0807CE563 0807CE566 0807CE570 0807CE573 0807CE573 0807CE574 0807CE575 0807CE576 0807CE578 0807CE611 0807CE612 0807CE613 0807CE614 0807CE615 0807CE616 0807CE617 0807CE618 0807CE619 0807CE621 0807CE622 0807CE624 0807CE627 0807CE628 0807CE629 0807CE630 0807CE635 0807CE636 0807CE637 0807CE638 0807CE639 0807CE642 0807CE686 0807CE687 0807CE688 0807CE690 0807CE691 0807CE692 0807CE695 0807CE695 0807CE696 0807CE697 0807CE698 0807CE704 0807CE705 0807CE776 0807CE777 0807CE778 0807CE779 0807CE780 0807CE781 0807CE782 0808CE068 0808CE069 0808CE069 0808CE070 0808CE071 0808CE072 0808CE073 0808CE074 0808CE075 0808CE085 0808CE086 0808CE087 0808CE088 0808CE090 0808CE091 0808CE092 0808CE093 0808CE094 0808CE104 0808CE105 0808CE106 0808CE106 0808CE107 0808CE108 0808CE109 0808CE110 0808CE111 0808CE112 0808CE154 0808CE155 0808CE156 0808CE159 0808CE161 0808CE162 0808CE163 0808CE164 0808CE165 0808CE166 0808CE167 0808CE169 0808CE170 0808CE171 0808CE172 0808CE173 0808CE205 0808CE207 0808CE208 0808CE209 0808CE210 0808CE212 0808CE213 0808CE235 0808CE237 0808CE238 0808CE240 0808CE242 0808CE273 0808CE274 0808CE275 0808CE276 0808CE277 0808CE278 0808CE279 0808CE280 0808CE282 0808CE415 0808CE416 0808CE417 0808CE418 0808CE419 0808CE420 0808CE421 0808CE422 0808CE423 0808CE424 0808CE425 0808CE426 0808CE427 0808CE428 0808CE429 0808CE430 0808CE431 0808CE433 0808CE433 0808CE434 0808CE502 0808CE504 0808CE505 0808CE506 0808CE507 0808CE509 0808CE510 0808CE511 0808CE547 0808CE549 0808CE550 0808CE551 0808CE552 0808CE553 0808CE554 0808CE555 0808CE556 0808CE563 0808CE564 0808CE565 0808CE566 0808CE567 0808CE568 0808CE569 0808CE570 0808CE571 0808CE572 0808CE591 0808CE593 0808CE597 0808CE598 0808CE600 0808CE646 0808CE649 0808CE650 0808CE651 0808CE652 0808CE653 0808CE654 0809CE111 0809CE111 0809CE116 0809CE118 0809CE119 0809CE164 0809CE166 0809CE167 0809CE169 0809CE170 0809CE171 0809CE172 0809CE173 0809CE215 0809CE216 0809CE217 0809CE219 0809CE220 0809CE221 0809CE222 0809CE223 0809CE224 0809CE238 0809CE239 0809CE240 0809CE241 0809CE242 0809CE292 0809CE293 0809CE294 0809CE441 0809CE465 0809CE466 0809CE467 0809CE468 0809CE469 0809CE470 0809CE471 0809CE472 0809CE473 0809CE474 0809CE531 0809CE532 0809CE533 0809CE534 0809CE562 0809CE563 0809CE564 0809CE565 0809CE566 0809CE567 0809CE568 0809CE569 0810CE021 0810CE062 0810CE064 0810CE130 0810CE131 0810CE132 0810CE133 0810CE134 0810CE143 0810CE144 0810CE145 0810CE146 0810CE147 0810CE148 0810CE149 0810CE150 0810CE151 0810CE152 0810CE163 0810CE164 0810CE165 0810CE166 0810CE167 0810CE168 0810CE169 0810CE170 0810CE171 0810CE172 0810CE176 0810CE177 0810CE178 0810CE179 0810CE180 0810CE188 0810CE191 0810CE223 0810CE262 0810CE264 0810CE286 0810CE293 0810CE294 0810CE295
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed throughout the US and to Argentina, Brazil, Canada, Chile and Latin America, as well as to 16 government facilities.
  • Product Description
    Pnemosure Insufflators, model numbers 620-040-600 and 620-040-610, manufactured by Stryker Endoscopy, San Jose, CA.
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • Manufacturer Address
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA