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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0790-2025

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Publicado el 8 de enero de 2025 · Inicio del retiro: 21 de noviembre de 2024

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

Qué peligro representa

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
MEDLINE INDUSTRIES, LP - Northfield
Distribuidor
Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
Lote
1) REF CDS780162AA, UDI/DI 10193489262049 (EA) 40193489262040 (CS), Lot Numbers: 20BBO888, 20BBQ352, 20FBR735; 2) REF CDS780162AB, UDI/DI 10193489338447 (EA) 40193489338448 (CS), Lot Numbers: 20GBF853; 3) REF CDS780162AC, UDI/DI 10193489383911 (EA) 40193489383912 (CS), Lot Numbers: 20HBE537, 20IBB263, 20JBB811, 20KBA268, 20LBM232, 21ABA833; 4) REF CDS780162AD, UDI/DI 10193489498950 (EA) 40193489498951 (CS), Lot Numbers: 21ABU170, 21BBQ045, 21DBD059, 21DBS617, 21GBS609, 21HBB525; 5) REF CDS780162X, UDI/DI 10889942840281 (EA) 40889942840282 (CS), Lot Numbers: 19ABX591, 19BBM085, 19CBM932, 19EBF768, 19EBU016, 19EBY613, 19FBI652, 19GBV765; 6) REF CDS780162Y, UDI/DI 10193489694079 (EA) 40193489694070 (CS), Lot Numbers: 19HBC545, 19HBD425, 19JBG849, 19LBO181, 19RBB546, 19VBH579; 7) REF CDS780208F, UDI/DI 10193489494211 (EA) 40193489494212 (CS), Lot Numbers: 21FBD429, 22ABH903, 22BBQ627, 22DBL468, 22EBM543, 22HBH464, 22IBN540, 22KBM775, 23ABM574, 23ABU440; 8) REF CDS981327N, UDI/DI 10889942959273 (EA) 40889942959274 (CS), Lot Numbers: 19ABN030, 19DBH383, 19EBJ379, 19GBI961, 19HBU954, 19JBK986, 19LBW564, 20CBH905, 20EBS213, 20GBU395; 9) REF CDS981327O, UDI/DI 10193489396782 (EA) 40193489396783 (CS), Lot Numbers: 20JBO709, 20LBM343, 20LBM792, 21CBE183, 21DBJ732; 10) REF CDS981327P, UDI/DI 10193489930825 (EA) 40193489930826 (CS), Lot Numbers: 21KBO532, 22ABE609; 11) REF CDS981327Q, UDI/DI 10195327080365 (EA) 40195327080366 (CS), Lot Numbers: 22BMC351, 22BMG728, 22FMF883, 22FMH830, 22GMH480, 22IMA515, 22KMF960, 22KMF961, 22LMC560, 23BMG193, 23BMG197, 23BMH848, 23CMF104, 23FMF213, 23GME170, 23IMB313, 23IMG472, 23JMG480, 23KMF371; 12) REF CDS982683Q, UDI/DI 10193489463668 (EA) 40193489463669 (CS), Lot Numbers: 21IBO697, 21IBW821, 21JBQ897, 21KBX752, 21LBI690, 22ABL244, 22EBL552, 22FBN421, 22OBC365, 13) REF CDS983383F, UDI/DI 10889942654956 (EA) 40889942654957 (CS), Lot Numbers: 19BBK956, 19CBT696, 19FBQ922, 19GBO356, 19IBN865, 19KBC420, 19PBC874, 19SBE336, 20ABR692, 20BBT769, 20EBC279, 20IBR042, 20JBO007, 20KBY260, 20VBB245, 21ABG325; 14) REF CDS983470F, UDI/DI 10193489919790 (EA) 40193489919791 (CS), Lot Numbers: 21HDA904, 21IDC397, 21KDA963, 22BDC488, 22DDC383, 22IDB637, 22JDA524, 22KDC130, 23ADB517, 23BDB720, 23EDA487; 15) REF CDS983470G, UDI/DI 10195327457969 (EA) 40195327457960 (CS), Lot Numbers: 23IDB666, 23JDA519; 16) REF CDS983480C, UDI/DI 10889942730575 (EA) 40889942730576 (CS), Lot Numbers: 19CDC524, 19FDA486, 19HDA529, 19JDB849, 20ADC747; 17) REF CDS984297G, UDI/DI 10889942727056 (EA) 40889942727057 (CS), Lot Numbers: 19ABS411, 19DBC216, 19EBD784, 19FBA807, 19GBT163, 19IBA007, 19IBI546, 19IBW342, 19KBG656, 19LBF068, 19QBC744, 20ABS233, 20BBK648, 20DBK821, 20EBC094, 20GBC958, 20JBD419, 20JBI324, 20JBS770, 20LBM854, 21CBU578, 21DBP519, 21EBK875, 21HBC361, 21HBC545, 21JBA878, 21JBF855, 22ABB092, 22BBJ452, 22BBJ453, 22GBI993, 22GBT350, 22IBR909, 22JBU173, 23ABO242, 23ABP041, 23BBU266; 18) REF CDS984323F, UDI/DI 10889942724970 (EA) 40889942724971 (CS), Lot Numbers: 19ABO137, 19BBM051, 19DBK006, 19EBS741, 19FBH808, 19FBV744, 19IBJ102, 19LBH113, 20BBI289, 20BBU831, 20EBO299, 20GBH177, 20JBQ492, 20KBK336, 20WBG127, 21BBN565, 21CBZ730, 21GBH414, 21HBE554, 21IBM834, 21JBS165, 22CBM688, 22EBV334; 19) REF CDS984323G, UDI/DI 10195327173944 (EA) 40195327173945 (CS), Lot Numbers: 22IBS382, 22JBA696, 22KBW048, 22LBN379, 23BBI976, 23CBO815, 23DBF796, 23DBQ245; 20) REF CDS984496G, UDI/DI 10889942688616 (EA) 40889942688617 (CS), Lot Numbers: 19CBN550, 19FBL249, 19HBP406, 19HBU953, 19KBK454; 21) REF CDS984496I, UDI/DI 10193489242546 (EA) 40193489242547 (CS), Lot Numbers: 20ABP019, 20BBQ366, 20EBI799, 20GBE682, 20HBI797, 20JBA350, 20KBD966, 20WBA495, 21ABE016, 21CBT384, 21EBK821, 21FBA962, 21HBE074, 21IBV598, 21VBA233, 22DBS440, 22DBT289, 22FBW276, 22GBH595, 22IBP436, 22IBT782, 22KBU365, 22LBE934, 22OBK705, 23ABD970, 23DBH556; 22) REF CDS984505F, UDI/DI 10889942688593
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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