Events

Rappel de Device Recall LifeStyles, Contempo and Prime color and assorted flavored

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Ansell Healthcare Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    25095
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0401-03
  • Date de mise en oeuvre de l'événement
    2002-11-25
  • Date de publication de l'événement
    2002-12-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2003-10-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25146
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Condom - Product Code HIS
  • Cause
    The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards.
  • Action
    Recall letters dated 11/25/02 were issued to direct accounts via U.S. Mail, asking wholesalers to stop distribution of the lot, return stocks on hand, and conduct a recall to the retail level.

Device

Device Recall LifeStyles, Contempo and Prime color and assorted flavored
  • Modèle / numéro de série
    LOT NUMBER PRODUCT CODE DESCRIPTION 0912C04222 4535 CONTEMPO INTENSITY 3''S 0912C04022 5300 LS ASST COLORS STPS 1000''S 0912C03822 4535 CONTEMPO INTENSITY 3''S 0912C03722 3300 PRIME ASST. COLOR STRIPS 1000 0912C03622 3300 PRIME ASST. COLOR STRIPS 1000 0912C01022 2812 LS ASSORTED COLORS 12''S 0912C00922 2803 LS ASSORTED COLORS 3''S 0912C00922 2812 LS ASSORTED COLORS 12''S 0912C00822 2812 LS ASSORTED COLORS 12''S 0912C00722 5300 LS ASST COLORS STPS 1000''S 0912C00622 5300 LS ASST COLORS STPS 1000''S 0912C00522 5300 LS ASST COLORS STPS 1000''S 0912C00422 5300 LS ASST COLORS STPS 1000''S 0912C00322 5300 LS ASST COLORS STPS 1000''S 0912C00222 5300 LS ASST COLORS STPS 1000''S 0912C00122 5300 LS ASST COLORS STPS 1000''S 0911C03522 4546 CONTEMPO INTENSITY STPS 1000 0911C00922 2803 LS ASSORTED COLORS 3''S 0911C00822 5300 LS ASST COLORS STPS 1000''S 0911C00722 2803 LS ASSORTED COLORS 3''S 0911C00722 5300 LS ASST COLORS STPS 1000''S 0911C00622 5300 LS ASST COLORS STPS 1000''S 0911C00522 5300 LS ASST COLORS STPS 1000''S 0911C00422 5300 LS ASST COLORS STPS 1000''S 0911704022 1246 LS COLOR DISCS 6''S 0911703922 1246 LS COLOR DISCS 6''S 0911703822 1246 LS COLOR DISCS 6''S 0911703622 1243 LS COLOR DISCS 3''S 0910C02822 4546 CONTEMPO INTENSITY STPS 1000 0910C01322 3300 PRIME ASST. COLOR STRIPS 1000 0910C01222 5303 LS ASSORTED COLORS FP 3''S 0910C01022 5303 LS ASSORTED COLORS FP 3''S 0910C00922 5300 LS ASST COLORS STPS 1000''S 0910C00822 5300 LS ASST COLORS STPS 1000''S 0910C00722 5300 LS ASST COLORS STPS 1000''S 0910C00622 5300 LS ASST COLORS STPS 1000''S 0910C00522 5300 LS ASST COLORS STPS 1000''S 0910C00422 5300 LS ASST COLORS STPS 1000''S 0910C00322 5300 LS ASST COLORS STPS 1000''S 0910C00222 5300 LS ASST COLORS STPS 1000''S 0910C00122 5300 LS ASST COLORS STPS 1000''S 0909C03022 5300 LS ASST COLORS STPS 1000''S 0909C02922 1246 LS COLOR DISCS 6''S 0909C02822 1246 LS COLOR DISCS 6''S 0909C02622 5303 LS ASSORTED COLORS FP 3''S 0909C02122 5303 LS ASSORTED COLORS FP 3''S 0909C01922 5303 LS ASSORTED COLORS FP 3''S 0909C01822 4546 CONTEMPO INTENSITY STPS 1000 0909C01722 4535 CONTEMPO INTENSITY 3''S 0909C01622 4535 CONTEMPO INTENSITY 3''S 0909C01322 5300 LS ASST COLORS STPS 1000''S 0909C01222 5300 LS ASST COLORS STPS 1000''S 0909C01122 5300 LS ASST COLORS STPS 1000''S 0909C01022 5300 LS ASST COLORS STPS 1000''S 0909C00922 5300 LS ASST COLORS STPS 1000''S 0909C00822 5300 LS ASST COLORS STPS 1000''S 0909C00122 5300 LS ASST COLORS STPS 1000''S 0908C05222 2803 LS ASSORTED COLORS 3''S 0908C05122 5300 LS ASST COLORS STPS 1000''S 0908C05022 5300 LS ASST COLORS STPS 1000''S 0908C04922 2803 LS ASSORTED COLORS 3''S 0908C04922 5300 LS ASST COLORS STPS 1000''S 0908C02122 5300 LS ASST COLORS STPS 1000''S 0908C02022 5300 LS ASST COLORS STPS 1000''S 0908C01922 5300 LS ASST COLORS STPS 1000''S 0908C01822 5300 LS ASST COLORS STPS 1000''S 0908C01722 5300 LS ASST COLORS STPS 1000''S 0908C01622 5300 LS ASST COLORS STPS 1000''S 0908C01522 5300 LS ASST COLORS STPS 1000''S 0908C01422 5300 LS ASST COLORS STPS 1000''S 0908C01322 5300 LS ASST COLORS STPS 1000''S 0908C01222 5300 LS ASST COLORS STPS 1000''S 0908C01122 5300 LS ASST COLORS STPS 1000''S 0908C01022 5300 LS ASST COLORS STPS 1000''S 0908C00922 5300 LS ASST COLORS STPS 1000''S 0908C00822 5300 LS ASST COLORS STPS 1000''S 0908C00722 5300 LS ASST COLORS STPS 1000''S 0908C00622 5300 LS ASST COLORS STPS 1000''S 0908C00522 5300 LS ASST COLORS STPS 1000''S 0908C00422 5300 LS ASST COLORS STPS 1000''S 0908C00322 5300 LS ASST COLORS STPS 1000''S 0908C00222 5300 LS ASST COLORS STPS 1000''S 0908C00122 5300 LS ASST COLORS STPS 1000''S 0001990522 5300 LS ASST COLORS STPS 1000''S 0001990622 5300 LS ASST COLORS STPS 1000''S 0001990722 5300 LS ASST COLORS STPS 1000''S 0001991222 5310 LS ASST CLRS NON LUB STPS 1000 0001992022 2803 LS ASSORTED COLORS 3''S 0002990622 2812 LS ASSORTED COLORS 12''S 0002991122 5300 LS ASST COLORS STPS 1000''S 0002991222 5300 LS ASST COLORS STPS 1000''S 0002991822 5300 LS ASST COLORS STPS 1000''S 0002991922 5300 LS ASST COLORS STPS 1000''S 0002992022 5300 LS ASST COLORS STPS 1000''S 0002992122 5300 LS ASST COLORS STPS 1000''S 0002992222 5300 LS ASST COLORS STPS 1000''S 0002992322 5300 LS ASST COLORS STPS 1000''S 0002992422 5300 LS ASST COLORS STPS 1000''S 0002992522 5300 LS ASST COLORS STPS 1000''S 0002992622 5300 LS ASST COLORS STPS 1000''S 0002992722 5300 LS ASST COLORS STPS 1000''S 0002992822 5300 LS ASST COLORS STPS 1000''S 0004000302 4560 CONTEMPO PRPK 60 PKGS 3''S 0004991022 2803 LS ASSORTED COLORS 3''S 0004991122 7600 LS COLOR DISCS 1000''S 0004991122 7644 LS COLOR DISCS 144''S 0004991222 4535 CONTEMPO INTENSITY 3''S 0004991522 4535 CONTEMPO INTENSITY 3''S 0004991622 4535 CONTEMPO INTENSITY 3''S 0005000602 4551 CONTEMPO PRPK COUNTER DISP 3''S 0005750500 1226 LS FLAVORED DISCS 6''S 0005991122 5300 LS ASST COLORS STPS 1000''S 0005991222 5300 LS ASST COLORS STPS 1000''S 0005991322 5300 LS ASST COLORS STPS 1000''S 0005991422 5300 LS ASST COLORS STPS 1000''S 0005991522 5300 LS ASST COLORS STPS 1000''S 0005991622 5300 LS ASST COLORS STPS 1000''S 0005991722 5300 LS ASST COLORS STPS 1000''S 0005991822 5300 LS ASST COLORS STPS 1000''S 0005991922 5300 LS ASST COLORS STPS 1000''S 0005992022 5300 LS ASST COLORS STPS 1000''S 0005992122 5300 LS ASST COLORS STPS 1000''S 0005992222 5300 LS ASST COLORS STPS 1000''S 0005992322 5300 LS ASST COLORS STPS 1000''S 0005992422 5300 LS ASST COLORS STPS 1000''S 0005992622 1246 LS COLOR DISCS 6''S 0005992622 7644 LS COLOR DISCS 144''S 0006750400 1223 LS FLAVORED DISCS 3''S 0006750500 1226 LS FLAVORED DISCS 6''S 0006990122 4535 CONTEMPO INTENSITY 3''S 0006990222 4546 CONTEMPO INTENSITY STPS 1000 0006990522 3300 PRIME ASST. COLOR STRIPS 1000 0006990622 5310 LS ASST CLRS NON LUB STPS 1000 0006990722 5300 LS ASST COLORS STPS 1000''S 0006990822 5300 LS ASST COLORS STPS 1000''S 0006990922 5300 LS ASST COLORS STPS 1000''S 0006991022 4535 CONTEMPO INTENSITY 3''S 0006991322 4546 CONTEMPO INTENSITY STPS 1000 0006991422 3300 PRIME ASST. COLOR STRIPS 1000 0007000902 4551 CONTEMPO PRPK COUNTER DISP 3''S 0007001002 4560 CONTEMPO PRPK 60 PKGS 3''S 0007990122 5300 LS ASST COLORS STPS 1000''S 0007990222 5300 LS ASST COLORS STPS 1000''S 0007990322 5300 LS ASST COLORS STPS 1000''S 0007990422 5300 LS ASST COLORS STPS 1000''S 0007990522 5300 LS ASST COLORS STPS 1000''S 0007990622 5300 LS ASST COLORS STPS 1000''S 0007990722 5300 LS ASST COLORS STPS 1000''S 0007990922 5310 LS ASST CLRS NON LUB STPS 1000 0007991822 5300 LS ASST COLORS STPS 1000''S 0007991922 5300 LS ASST COLORS STPS 1000''S 0008000102 4560 CONTEMPO PRPK 60 PKGS 3''S 0008000302 1587 LS COLOR DISC DISPLAY 3''S 0008000502 4551 CONTEMPO PRPK COUNTER DISP 3''S 0008000602 4560 CONTEMPO PRPK 60 PKGS 3''S 0008000702 4560 CONTEMPO PRPK 60 PKGS 3''S 0008000802 4551 CONTEMPO PRPK COUNTER DISP 3''S 0008750100 1221 LS FLAVORED DISC 1''S 0008980222 6800 LS LUSCIOUS FLAVORS 1000''S 0008980322 2713 LS FLAVORS 12''S 0008980422 6800 LS LUSCIOUS FLAVORS 1000''S 0008990122 3300 PRIME ASST. COLOR STRIPS 1000 0008991322 5300 LS ASST COLORS STPS 1000''S 0008991422 5300 LS ASST COLORS STPS 1000''S 0008991522 5300 LS ASST COLORS STPS 1000''S 0008991622 5300 LS ASST COLORS STPS 1000''S 0008991722 5300 LS ASST COLORS STPS 1000''S 0008991822 5305 LS ASSORTED COLOR STRIPS 0008991922 5305 LS ASSORTED COLOR STRIPS 0009750600 1223 LS FLAVORED DISCS 3''S 0009750700 1226 LS FLAVORED DISCS 6''S 0009750900 7500 LS FLAVORED DISCS 1000''S 0009990122 4535 CONTEMPO INTENSITY 3''S 0009990222 5300 LS ASST COLORS STPS 1000''S 0009990322 5300 LS ASST COLORS STPS 1000''S 0009990422 5300 LS ASST COLORS STPS 1000''S 0009990522 5300 LS ASST COLORS STPS 1000''S 0009990622 5300 LS ASST COLORS STPS 1000''S 0009990722 5300 LS ASST COLORS STPS 1000''S 0009990822 2803 LS ASSORTED COLORS 3''S 0009991022 2803 LS ASSORTED COLORS 3''S 0009991422 4535 CONTEMPO INTENSITY 3''S 0009991522 4011 OLE STRIPS 1000''S 0009992322 1246 LS COLOR DISCS 6''S 0009992722 4011 OLE STRIPS 1000''S 0009993222 5310 LS ASST CLRS NON LUB STPS 1000 0009993622 5305 LS ASSORTED COLOR STRIPS 0009993722 5305 LS ASSORTED COLOR STRIPS 0009993822 5305 LS ASSORTED COLOR STRIPS 0009993922 5305 LS ASSORTED COLOR STRIPS 0009994022 1246 LS COLOR DISCS 6''S 0009994322 4011 OLE STRIPS 1000''S 0009994422 1243 LS COLOR DISCS 3''S 0009994622 5310 LS ASST CLRS NON LUB STPS 1000 0009994722 4011 OLE STRIPS 1000''S 0009995022 1246 LS COLOR DISCS 6''S 0009995122 4535 CONTEMPO INTENSITY 3''S 0009995222 5303 LS ASSORTED COLORS FP 3''S 0009995622 5305 LS ASSORTED COLOR STRIPS 0010000202 4560 CONTEMPO PRPK 60 PKGS 3''S 0010000302 4551 CONTEMPO PRPK COUNTER DISP 3''S 0010000702 1587 LS COLOR DISC DISPLAY 3''S 0010001202 4560 CONTEMPO PRPK 60 PKGS 3''S 0010001302 4551 CONTEMPO PRPK COUNTER DISP 3''S 0010001402 4560 CONTEMPO PRPK 60 PKGS 3''S 0010750600 2703 LS FLAVORS 3''S 0010980122 6800 LS LUSCIOUS FLAVORS 1000''S 0010980222 6800 LS LUSCIOUS FLAVORS 1000''S 0010980322 6800 LS LUSCIOUS FLAVORS 1000''S 0010980422 6844 LS LUSCIOUS FLAVORS 144''S 0010990122 4535 CONTEMPO INTENSITY 3''S 0010990722 2803 LS ASSORTED COLORS 3''S 0010990822 2803 LS ASSORTED COLORS 3''S 0010991022 5305 LS ASSORTED COLOR STRIPS 0010991122 2803 LS ASSORTED COLORS 3''S 0010991222 2803 LS ASSORTED COLORS 3''S 0010991322 2803 LS ASSORTED COLORS 3''S 0010991622 5310 LS ASST CLRS NON LUB STPS 1000 0011000702 4560 CONTEMPO PRPK 60 PKGS 3''S 0012000102 4551 CONTEMPO PRPK COUNTER DISP 3''S 0012000202 4560 CONTEMPO PRPK 60 PKGS 3''S 0012000502 4551 CONTEMPO PRPK COUNTER DISP 3''S 0012000602 4560 CONTEMPO PRPK 60 PKGS 3''S 0012000702 4560 CONTEMPO PRPK 60 PKGS 3''S 0012750200 2712 LS FLAVORS 12''S 0012750300 2712 LS FLAVORS 12''S 0012750400 1712-B LS BONUS PACK W/FREE FLAVOR DISC 0012980122 6800 LS LUSCIOUS FLAVORS 1000''S 0012980222 6800 LS LUSCIOUS FLAVORS 1000''S 0012980322 6844 LS LUSCIOUS FLAVORS 144''S 0101000502 4560 CONTEMPO PRPK 60 PKGS 3''S 0101001002 4551 CONTEMPO PRPK COUNTER DISP 3''S 0101750400 1226 LS FLAVORED DISCS 6''S 0101750500 7500 LS FLAVORED DISCS 1000''S 0101750600 7544 LS FLAVORED DISCS 144''S 0101750700 1226 LS FLAVORED DISCS 6''S 0101750800 1226 LS FLAVORED DISCS 6''S 0101750900 2712 LS FLAVORS 12''S 0101751000 2712 LS FLAVORS 12''S 0101751500 1226 LS FLAVORED DISCS 6''S 0101751600 1226 LS FLAVORED DISCS 6''S 0101751700 1226 LS FLAVORED DISCS 6''S 0101751800 1226 LS FLAVORED DISCS 6''S 0101752000 1226 LS FLAVORED DISCS 6''S 0101752100 1226 LS FLAVORED DISCS 6''S 0101752200 1226 LS FLAVORED DISCS 6''S 0101752300 1226 LS FLAVORED DISCS 6''S 0101752900 7544 LS FLAVORED DISCS 144''S 0101980122 6800 LS LUSCIOUS FLAVORS 1000''S 0101980222 2713 LS FLAVORS 12''S 0102000102 4551 CONTEMPO PRPK COUNTER DISP 3''S 0102000202 4560 CONTEMPO PRPK 60 PKGS 3''S 0102000402 4551 CONTEMPO PRPK COUNTER DISP 3''S 0102750100 2712 LS FLAVORS 12''S 0102750200 2712 LS FLAVORS 12''S 0102750600 1221 LS FLAVORED DISC 1''S 0102751000 2701 LS FLAVORS 1''S 0102751100 1712-B LS BONUS PACK W/FREE FLAVOR DISC 0102751200 1712-B LS BONUS PACK W/FREE FLAVOR DISC 0102751500 2712 LS FLAVORS 12''S 0102980122 6800 LS LUSCIOUS FLAVORS 1000''S 0103000602 4560 CONTEMPO PRPK 60 PKGS 3''S 0103000702 4551 CONTEMPO PRPK COUNTER DISP 3''S 0103750100 2712 LS FLAVORS 12''S 0103750200 2712 LS FLAVORS 12''S 0103750300 2712 LS FLAVORS 12''S 0104000802 4551 CONTEMPO PRPK COUNTER DISP 3''S 0104000902 4560 CONTEMPO PRPK 60 PKGS 3''S 0104001402 4551 CONTEMPO PRPK COUNTER DISP 3''S 0104750200 2712 LS FLAVORS 12''S 0104750300 2712 LS FLAVORS 12''S 0104750400 2712 LS FLAVORS 12''S 0104750500 2712 LS FLAVORS 12''S 0104750600 2712 LS FLAVORS 12''S 0104980122 2712 LS FLAVORS 12''S 0104980222 4550 CONTEMPO LUSCIOUS FLAVORS 3''S 0104980222 4552 CT LUSCIOUS FLAVORS 1000''S 0104980322 6800 LS LUSCIOUS FLAVORS 1000''S 0104980522 6800 LS LUSCIOUS FLAVORS 1000''S 0105000102 4560 CONTEMPO PRPK 60 PKGS 3''S 0105000202 1665 LS FLOOR DISPLAY 12''S 0105000302 4560 CONTEMPO PRPK 60 PKGS 3''S 0105000702 4560 CONTEMPO PRPK 60 PKGS 3''S 0105750500 2712 LS FLAVORS 12''S 0105750700 2712 LS FLAVORS 12''S 0105750900 1712-B LS BONUS PACK W/FREE FLAVOR DISC 0105751000 1712-B LS BONUS PACK W/FREE FLAVOR DISC 0105990322 5305 LS ASSORTED COLOR STRIPS 0105991722 5305 LS ASSORTED COLOR STRIPS 0106000902 4551 CONTEMPO PRPK COUNTER DISP 3''S 0106001002 4560 CONTEMPO PRPK 60 PKGS 3''S 0106001202 4551 CONTEMPO PRPK COUNTER DISP 3''S 0106750100 2712 LS FLAVORS 12''S 0106750100 2713 LS FLAVORS 12''S 0106991722 5300 LS ASST COLORS STPS 1000''S 0106992622 6000 LS ASST CLRS W/SPL STPS 1000''S 0106992722 6000 LS ASST CLRS W/SPL STPS 1000''S 0106992922 5300 LS ASST COLORS STPS 1000''S 0106993122 5300 LS ASST COLORS STPS 1000''S 0106993222 5300 LS ASST COLORS STPS 1000''S 0106993422 5300 LS ASST COLORS STPS 1000''S 0106993522 5300 LS ASST COLORS STPS 1000''S 0107000202 4551 CONTEMPO PRPK COUNTER DISP 3''S 0107000302 4560 CONTEMPO PRPK 60 PKGS 3''S 0107000402 4551 CONTEMPO PRPK COUNTER DISP 3''S 0107750700 2713 LS FLAVORS 12''S 0107751000 1713-B LS BONUS PACK W/FREE FLAVOR DISC 0107751100 2712 LS FLAVORS 12''S 0107751200 2712 LS FLAVORS 12''S 0107751300 1713-B LS BONUS PACK W/FREE FLAVOR DISC 0107980122 6800 LS LUSCIOUS FLAVORS 1000''S 0108000202 4551 CONTEMPO PRPK COUNTER DISP 3''S 0108000302 4560 CONTEMPO PRPK 60 PKGS 3''S 0108000502 4560 CONTEMPO PRPK 60 PKGS 3''S 0108000602 4551 CONTEMPO PRPK COUNTER DISP 3''S 0108750200 2712 LS FLAVORS 12''S 0109000302 4551 CONTEMPO PRPK COUNTER DISP 3''S 0110000302 0044 LS SAMPLER CASE 0110000902 4560 CONTEMPO PRPK 60 PKGS 3''S 0110750100 2703 LS FLAVORS 3''S 0110750400 2713 LS FLAVORS 12''S 0110750500 2713 LS FLAVORS 12''S 0112750100 2712 LS FLAVORS 12''S 0112750400 2703 LS FLAVORS 3''S 0201000202 4551 CONTEMPO PRPK COUNTER DISP 3''S 0201750800 2703 LS FLAVORS 3''S 0203000402 4551 CONTEMPO PRPK COUNTER DISP 3''S 0203000702 4560 CONTEMPO PRPK 60 PKGS 3''S 0203750200 1712-B LS BONUS PACK W/FREE FLAVOR DISC 0203750300 1712-B LS BONUS PACK W/FREE FLAVOR DISC 0203750900 2712 LS FLAVORS 12''S 0204000602 1565 LS PRPK 24 PKGS OF 3''S 0205750500 2713 LS FLAVORS 12''S 0205750600 2712 LS FLAVORS 12''S 0205750700 2712 LS FLAVORS 12''S 0205750800 2712 LS FLAVORS 12''S 0205750800 2713 LS FLAVORS 12''S 0205750900 2712 LS FLAVORS 12''S 0206750500 2703 LS FLAVORS 3''S 0206750600 2713 LS FLAVORS 12''S 0206750700 2712 LS FLAVORS 12''S 0207750300 2713 LS FLAVORS 12''S
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Europe
  • Description du dispositif
    Assorted colored and flavored condoms: LifeStyles Luscious Flavors, Prime Assorted Colors, Contempo Luscious Flavors, Contempo Intensity Assorted Colors
  • Manufacturer
    Ansell Healthcare Inc

Manufacturer

Ansell Healthcare Inc
  • Adresse du fabricant
    Ansell Healthcare Inc, 1500 Industrial Road, Dothan AL 36303
  • Source
    USFDA