Events

Recall of Device Recall Latex Rebreathing Bags:

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Teleflex Medical Europe Ltd.

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
    79579
  • Event Risk Class
    Class 2
  • Event Number
    Z-1367-2018
  • Event Initiated Date
    2018-03-15
  • Event Date Posted
    2018-04-12
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162684
  • 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
    Bag, reservoir - Product Code BTC
  • Reason
    These products contain latex, but the following statement is not included on any level of product packaging: caution: this product contains natural rubber latex which may cause allergic reactions.
  • Action
    The firm initiated their field correction on 03/15/2018 by letter. The notices stated the following: Affected distributors are instructed to take the following actions: 1. Place a copy of this notification with each unit of affected product currently in your inventory. 2. Using the provided customer letter template and acknowledgment form, communicate this notification to any of your customers who have received product included within the scope of this notification. 3. Have each of your customers who received the affected product return a completed acknowledgment form to you. 4. Once you have finished collecting and consolidating all of the acknowledgment forms, from your customers and placing a copy of this notification with each unit of affected product in your inventory, please complete the enclosed Distributor Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document completion of this recall. Affected direct customers are instructed to take the following actions: 1. Place a copy of this notification with each unit of affected product currently in your inventory. Users should note This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. 2. After step (1) is complete, fill out the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. Upon finding additional lots, the firm issued additional letter on 06/27/2018 with the same message as the letter disseminated in March.

Device

Device Recall Latex Rebreathing Bags:
  • Model / Serial
    Product Code Equivalent Code (a) 151174050 151174 Batch Numbers: 11218023 11218024 7702798 8084124 8322324 8384447  (b) 153000005 153000005 Batch Numbers: 10263072 10565411 10636343 10742167 11078589 11105577 11188556 11301914 11390984 11644614 7889062 8021782 8055291 8080268 8217002 8774177 8972828 9038367 9038368 9038370 9123586 9284572 9387490 9416790 9515204   (c) 153000010 153000010 Batch Numbers: 10263073 10425381 10425382 10747907 10825066 11078590 11301915 11534382 11760316 11769838 11857438 8021783 8055292 8080269 8217003 8774176 8972829 9038372 9038373 9038374 9038375 9038376 9310179 9416791 9507992 9536655 9579791 9700489 9700490 9700491 9700492 9706325 9796522 9813690   (d) 153000020 153000020 Batch Numbers: 10147558 10346587 10379115 10690085 10825067 10846469 11078591 11105579 11188558 11390987 11534383 11769839 11857439 11873098 7889065 7889066 7889067 8293609 8384636 8563059 8774178 9038377 9038378 9038379 9038380 9038381 9219953 9249360 9498125 9608313 9796523 9933121 9933123  (e) 153000030 153000030 Batch Numbers:  10026945 10026946 10056453 10142568 10209248 10400856 10747908 10825068 10907835 11003798 11078592 11078593 11450496 11458647 11620321 11704031 12079373 12527197 7176396 7668817 7889068 8055293 8080271 8217004 8384637 8465218 8752941 8774180 8939533 8972831 9038382 9038384 9097574 9249361 9473122 9595217 9595218 9700495 9700496 9700497 9796524 12790887 (added 27 JUN 18)  (f) 153000050 153000050 Batch Numbers: 10236105 10508208 10614862 11078594 11078595 11562396 8021784 8384638 8725825 9038386 9444407   (g) 210700050 2107050 Batch Numbers: 10216572 10263076 10521582 10772448 10846470 11301920 11534384 11644615 11769841 12055032 12827654 13064537 9140498 9176058 9176059 9238630 9656895   (h) 210700102 2107102 Batch Numbers: 10026947 10026948 10147559 10147560 10147561 10263077 10286580 10509798 10565412 10565413 10608966 10636346 10636347 10664670 10703604 10747910 10747911 10747912 10747913 10803495 10983299 10983300 10983301 10983302 11078596 11078597 11078598 11082030 11105580 11112325 11188560 11218434 11218435 11218436 11218437 11226804 11258122 11281305 11301921 11301922 11534385 11596196 12827659 12827660 12827661 13064542 13064543 13229539 13229540 7702956 7702957 7702958 7889071 7889077 8055294 8080272 8293610 8384640 8563060 8725826 8774182 8972832 9038387 9038388 9038389 9038390 9038391 9038392 9038393 9038394 9038395 9038396 9038397 9038398 9038399 9038400 9038401 9038402 9038403 9038404 9038405 9038406 9038407 9038408 9038409 9038410 9038411 9038412 9038413 9038414 9038415 9038416 9038417 9038418 9038419 9038420 9038421 9100521 9176060 9176061 9176062 9176063 9226593 9249362 9284574 9348599 9427085 9515205 9548568 9579792 9579793 9579794 9608315 9608316 9706326 9727277 9727278 9727279 9727280 9754641 9754642 9754643 9796526 9813692 9844604 9876240 9904759 9904760 9960837 9960838 9982977 13293979 (added 27 JUN 18)  (I) 210700202 2107202 Batch Numbers: 10026951 10026952 10147563 10204662 10263078 10263079 10362219 10400859 10400860 10400861 10407821 10508210 10508211 10508212 10614863 10636349 10690086 10747914 10747916 10747917 10747918 10935788 10983304 10983306 10983307 10983308 11078599 11078600 11078601 11082031 11105581 11112327 11218439 11226805 11258123 11281306 11301924 11390989 11390990 11421418 11503298 11503299 11503300 11534386 11596198 11644621 11644622 11644623 11644624 11644625 11747118 11747119 11747120 12827693 12827695 13037774 13037785 13064578 7702959 7702960 7702961 7889086 7889090 8080273 8217005 8462765 8462767 8465219 8465220 8546642 8691281 8725827 8774183 8893278 8972833 9038423 9038424 9038425 9038426 9038427 9038428 9038429 9038430 9038431 9038432 9038433 9038434 9038435 9038436 9038437 9038438 9038439 9038440 9038441 9038442 9038443 9038444 9038445 9038447 9038448 9038449 9038450 9038451 9038452 9038453 9038454 9038455 9092269 9100522 9105434 9127416 9131263 9176064 9284575 9284576 9284577 9310180 9495387 9495388 9495389 9495390 9543143 9543144 9563189 9586588 9608319 9608320 9706327 9754644 9788717 9788718 9788719 9788720 9788721 9789990 9849775 9863755 9876241 9904761 9933128 9960839 9982978 13294014 (added 27 JUN 18) 13436249 (added 27 JUN 18)  (j) 210700302 2107302 Batch Numbers: 10147566 10263081 10286584 10286585 10286586 10286587 10379116 10379117 10402212 10509800 10608967 10636350 10636351 10636352 10747919 10747920 10747921 10747922 10747923 10772449 10846473 10983309 10983310 10983311 10983312 10983313 11077681 11078602 11078603 11078604 11105582 11188562 11218440 11218441 11218442 11218443 11226806 11258124 11281307 11301925 12827729 12827730 12827731 13064614 13226011 13226035 13229543 7702963 7702964 7702965 7889117 7976017 8013070 8013194 8080274 8217006 8293611 8465223 8563062 8665961 8725828 8774184 8972834 9038457 9038458 9038459 9038460 9038461 9038462 9038463 9038464 9038465 9038466 9038467 9038468 9038469 9038470 9038471 9038472 9038473 9038474 9038475 9038476 9038477 9038478 9038479 9038480 9038481 9038482 9038483 9038484 9038485 9038486 9038487 9038488 9038489 9038490 9054954 9100523 9176068 9176069 9176070 9284578 9284579 9387493 9416792 9495392 9701523 9727281 9727282 9727283 9754645 9796527 9813695 9813696 9813697 9904762 9933129 9933130 9933131 13294050 (added 27 JUN 18) 13294051 (added 27 JUN 18)  (k) 210700402 2107402 Batch Numbers: 10236106 10263082 10263083 10286588 10286589 10346588 10425384 10480127 10508213 10508214 10508215 10508216 10508217 10521583 10536133 10614864 10636354 10636355 10747924 10747925 10747926 10747927 10959881 10983314 10983315 11003800 11078605 11078606 11105583 11188563 11218444 11281308 11301927 11301928 11390994 11390995 11390996 12827764 12827765 12827766 13064650 13064651 13154082 13154083 13247605 7446834 7702967 7702968 7889119 7976018 8021785 8080275 8293612 8384641 8462768 8462769 8462770 8462771 8462772 8725829 8774185 9038491 9038492 9038493 9038494 9038495 9038496 9038497 9038498 9038499 9038500 9038501 9038502 9038503 9038504 9038505 9038506 9038507 9038508 9038509 13294084 (added 27 JUN 18) 13294085 (added 27 JUN 18)  (l) 210700502 2107502 Batch Numbers: 10056455 10147570 10147571 10263084 10286590 10317922 10317923 10412854 10636358 10747930 10747931 10747932 10825069 10846475 10846476 10983316 10983317 10983318 10983319 10983320 10983321 10983322 11029938 13064673 13154103 7651422 7702970 7702971 7889130 7976019 8021786 8055295 8080276 8080277 8217008 8462773 8462774 8462775 8462776 8462777 8774187 8882502 8956720 8968201 8974312 9038514 9038515 9038516 9038517 9038518 9038519 9038520 9100525 9176073 9176074 9176075 9284585 9284586 9284587 9284588 9284589 9387494 9387495 9515209 9520766 9543145 9608326 9608327 9608328 9638433 9712666 9789991 9813698 9904764 9933134 9933135 9933136 13241637 (added 27 JUN 18) 13294106 (added 27 JUN 18)  (m) 210700602 2107602 Batch Numbers: 11153388 11318217 11545047 11644634 11844638 11873099 12171915 13241654 7651423 7889138 8021787 8055296 8293613 8513613 8774186 8972835 9038524 9038525 9038526 9038527 9038528 9100526 9284590 9284591
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Latex Rebreathing Bags: || Product Code Equivalent Code || (a) 151174050 151174 || (b) 153000005 153000005 || (c) 153000010 153000010 || (d) 153000020 153000020 || (e) 153000030 153000030 || (f) 153000050 153000050 || (g) 210700050 2107050 || (h) 210700102 2107102 || (I) 210700202 2107202 || (j) 210700302 2107302 || (k) 210700402 2107402 || (l) 210700502 2107502 || (m) 210700602 2107602 || Product Usage: || Rebreathing Bag is indicated for manual patient ventilation or in connection with anaesthesia apparatus and/or patient ventilators.
  • Manufacturer
    Teleflex Medical Europe Ltd

Manufacturer

Teleflex Medical Europe Ltd
  • Manufacturer Address
    Teleflex Medical Europe Ltd, Ida Business Park, Athlone Ireland
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA