FDAFDA · Food and drugs·Recall number Z-0790-2025
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Published January 8, 2025 · Recall initiated: November 21, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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