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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0718-2014

Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only

Publicado el 22 de enero de 2014 · Inicio del retiro: 9 de septiembre de 2011

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Recall was initiated due to the observation of separation between clear layers of the pouch during real time aging studies. As a result, it is possible to have a breach in the sterile barrier.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
The Anspach Effort, Inc.
Distribuidor
Worldwide Distribution - USA (nationwide) and the countries of Japan, Canada, Nigeria, Guam, China, Czech Republic, Thialand, Ecuador, Lithuania, Argentina, Turkey, Cayman Island, Jamaica, India, Jordan, Germany, Brazil, Mexico, Israel, Cameroon, Switzerland, South Africa, Greece, Finland, Taiwan, Hong Kong, France, Spain, Cyprus, Australia, United Kingdom, Sweden, Bahama, Korea, Malaysia, Iceland, Portugal, Polan, Austria, Belgium, Egypt, Singapore, Netherland, Arab Emirates, Kenya, Italy, Venezula, Columbia, Dominican Republic, Chile, Panama, Honduras, Costa Rica, Philippines.
Lote
A-CRN B123005578 LHD-6AC 8123005628 Q08-4B 311838 5-6R 333195 A-CRN B143006072 LH0-6AC 8393012282 QD8-4B 312583 S-6R 333458 A-CRN B183006882 LHD-6AC (463028357 Q08-4B 315793 S-6R 333793 A-CRN B213007929 LHD-6AC 8423013160 QD8-4B 316956 S-6R 333982 A-CRN 8313010424 LHD-6AC (253022922 QD8-48 317934 S-6R 334093 A-CRN 8373011925 LHD-6AC B073004408 008-48 318394 S-6R 334236 A-CRN 8393012268 LHD-6AC B373011840 Q08-48 319435 S-6R 334455 A-CRN 8393012369 LHD-6AC 093020161 Q08-48 319991 5-6R 334640 A-CRN 8393012486 LHD-6AC (243022710 008-48 330615 S-6R 334925 A-CRN 8433013376 LHD-6AC (303024122 Q08-4B 331283 S-6R 335148 A-CRN 8493014144 LHD-6AC 8243008895 Q08-4B 50220710 S-6R 335723 A-CRN 8513015111 LHD-6AC (423027109 Q08-4B 50244135 S-6R 335922 A-CRN B513015587 LHD-6AC 8283009782 Q08-4B 50288181 S-6R 336059 A-CRN 8533015857 LHD-6AC 8473013675 QD8-4B 50335706 S-6R 336180 A-CRN (083017208 LHD-6AC 023018999 Q08-48 50416854 S-6R 336 A-CRN-S-4 C353025392 M-2DC 611433 Q08-58 621855 5-9AC 621199 ADG-10 8233008614 M-2DC 611434 Q08-58 621856 5-9AC 621898 ADG-10 8283009851 M-2DC 611435 Q08-58 621857 5-9AC 621899 ADG-10 8513014221 M-2DC 611436 QD8-58 621858 5-9AC 621900 ADG-10 C123019873 M-2DC 611437 QD8-58 621859 S-9AC 621901 ADG-10 8113005441 M-2DC 611438 QD8-58 621860 5-98 314753 ADG-10 8103005121 M-2DC 611439 Q08-58 621861 5-98 317985 ADG-10 C453027963 M-2DC 616669 QD8-58 622850 5-98 332848 ADG-10 C033015647 M-2DC 616670 Q08-58 622851 5-98 50417033 ADG-10 A483000896 M-2DC 616671 Q08-58 622852 5-98 50430130 ADG-10 8453014133 M-2DC 616672 Q08-58 622853 5-98 50463416 ADG-10 C253022551 M-2DC 616673 Q08-58 622854 5-98 C213021763 ADG-10 A513001807 M-2DC 619860 QDS-58 622855 5-98 C393026383 ADG-10 C353024460 M-2DC 619861 Q08-58 622856 5-98 C413027012 ADG-10 8403012560 M-2DC 619862 Q08-58 622857 5-98 0353038977 ADG-10 320195 M-2DC 619863 Q08-58 622858 5-98 (143019969 ADG-10 331336 M-20C 622494 QD8-58 622859 5-98 C443027778 ADG-10 332219 M-20C 622495 Q08-58A 8163006509 S-98 8043003077 ,A.DG-10 332714 M-20C 622496 Q08-58A 8243007994 5-98 C243022436 ADG-10 332877 M-20C 622497 Q08-58A 8483013885 5-9B C423027143 ADG-10 333358 M-20C 622498 Q08-58A 8503015696 S-9B 8513015573 ADG-10 335066 M-2DC 622499 Q08-58A 8253007995 5-98 (143018884 ADG-10 336140 M-258 306394 Q08-58A A483000927 S-98 332346 ADG-10 603411 M-258 313462 QD8-58A C033015827 5-98 A493001246 ADG-10 603412 M-258 50287916 QD8-58A A453000254 S-98 A503001500 ADG-10 616185 M-258 50360067 QD8-58A 8183006864 5-98 8023002194 ADG-10 616186 M-258 50394293 Q08-58A 8333010928 5-98 8263009381 ADG-10 616187 M-258 50428120 Q08-58A 8403012674 5-98 8303010188 ADG-10 616188 M-258 A463000461 Q08-58A 8413012854 5-98 8503014075 ADG-10 616189 M-258 8393012498 Q08-58A 300444 5-98 C083016950 ADG-10 616190 M-258 8493013745 Q08-58A 319449 5-98 (103018223 ADG-10 616191 M-258 8513015561 QD8-58A 320226 5-98 C253022835 ,A.DG-10 616192 M-258 306091 QD8-58A 330194 5-98 C423027144 ADG-10 616193 M-258 8063003857 Q08-58A 333082 5-98 E033044288 ADG-10 616194 M-258 8083004766 QD8-58A 334556 S-98 E183049746 ADG-10 616195 M-258 8273009625 Q08-58A 603376 $-98 8073004272 ADG-10 616196 M-258 8333010997 Q08-58A 603377 S-98 8083004562 ADG-10 621224 M-258 8353011349 Q08-58A 603378 S-98 8353011350 ADG-10 622021 M-258 8083004773 Q08-58A 603379 S-9B 8443013480 ADG-11 305747 M-258 330220 QD8-58A 603380 5-98 8473014073 ADG-11 314669 M-258 330722 QD8-58A 616300 5-98 C463028216 ADG-11 319612 M-258 331065 QD8-58A 616301 5-98 C473028446 ADG-11 330692 M-258 331453 QD8-58A 616302 5-98 C493028956 ADG-11 333660 M-258 333651 QD8-58A 616303 5-98 CS13029360 ,A.DG-11 333857 M-258 334732 Q08-58A 616304 5-98 0033030570 ADG-11 334334 M-258 335134 Q08-58A 616305 5-98 0343038698 ADG-11 50440769 M-258 602092 Q08-58A 616306 5-98 E073046097 ADG-11 312969 M-258 602093 Q08-58A 623036 5-98 E113047380305 AOG-11 610279 M-250 8083004565 008-50 610155 5-98 611571 AOG-11 610280 M-250 8413012888 Q08-50 610156
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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