FDAFDA · Food and drugs·Recall number Z-3042-2024

Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA; 2) CORONARY ANGIO PACK-LF, Pack Number 00-401594R ; 3) IR NEURO INTERVENTIONAL PACK, Pack Number 00-401808S ; 4) NEURO CDS , Pack Number CDS780056K ; 5) NEURO CDS , Pack Number CDS780056L ; 6) SHUNT CDS-LF, Pack Number CDS780103K ; 7) NEURO CDS , Pack Number CDS780108T ; 8) NEURO LAMINECTOMY-LF, Pack Number CDS780109M ; 9) NEURO LAMINECTOMY-LF, Pack Number CDS780109N ; 10) NEURO LAMINECTOMY-LF, Pack Number CDS780109O ; 11) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119T ; 12) NEURO CDS , Pack Number CDS780162AA; 13) NEURO CDS , Pack Number CDS780162AB; 14) NEURO CDS , Pack Number CDS780162AC; 15) NEURO CDS , Pack Number CDS780162AD; 16) NEURO CDS , Pack Number CDS780162X ; 17) NEURO CDS , Pack Number CDS780162Y ; 18) BASIC NEURO PROCEDURE , Pack Number CDS780202K ; 19) BASIC NEURO PACK, Pack Number CDS780202L ; 20) BASIC NEURO PACK, Pack Number CDS780202O ; 21) BASIC NEURO PACK, Pack Number CDS780202P ; 22) BASIC NEURO PACK, Pack Number CDS780202Q ; 23) BASIC NEURO PACK, Pack Number CDS780202R ; 24) NEURO-LAMI CDS, Pack Number CDS780208D ; 25) NEURO-LAMI CDS, Pack Number CDS780208F ; 26) NEURO CDS, Pack Number CDS780230K; 27) NEURO CDS , Pack Number CDS780230K ; 28) VP SHUNT, Pack Number CDS840193U ; 29) NEURO CDS-LF, Pack Number CDS980853N ; 30) VP SHUNT CDS-LF , Pack Number CDS981084K ; 31) VP SHUNT CDS-LF , Pack Number CDS981084L ; 32) VP SHUNT CDS-LF , Pack Number CDS981084M ; 33) NEURO KIT , Pack Number CDS981327N ; 34) NEURO KIT , Pack Number CDS981327O ; 35) NEURO KIT , Pack Number CDS981327P ; 36) NERVE STIMULATOR, Pack Number CDS981579N ; 37) NEURO MINOR CDS , Pack Number CDS981708K ; 38) VP SHUNT CDS, Pack Number CDS981740F ; 39) VP SHUNT CDS, Pack Number CDS981740J ; 40) VP SHUNT CDS, Pack Number CDS981740K ; 41) VP SHUNT CDS, Pack Number CDS981740KH; 42) MICRO DISC CDS, Pack Number CDS981886P ; 43) MICRO DISC CDS, Pack Number CDS981886R ; 44) MICRO DISC CDS, Pack Number CDS981886S ; 45) NEURO BACK CDS QVH-LF , Pack Number CDS982527F ; 46) NEURO CDS , Pack Number CDS982603L ; 47) NEURO CDS , Pack Number CDS982603M ; 48) NEURO CDS , Pack Number CDS982603N ; 49) NEURO SPINE CDS , Pack Number CDS982683Q ; 50) MAJOR NEURO , Pack Number CDS982704K ; 51) MAJOR NEURO , Pack Number CDS982704M ; 52) MAJOR NEURO , Pack Number CDS982704N ; 53) NEURO CDS CHS-LF, Pack Number CDS982745D ; 54) NEURO CDS CHS-LF, Pack Number CDS982745F ; 55) NEURO CDS CHS-LF, Pack Number CDS982745G ; 56) AV SHUNT CDS, Pack Number CDS983098D ; 57) AV SHUNT CDS, Pack Number CDS983098F ; 58) ZALE V-P SHUNT CDS, Pack Number CDS983186D ; 59) ZALE V-P SHUNT CDS, Pack Number CDS983186F ; 60) ZALE V-P SHUNT CDS, Pack Number CDS983186G ; 61) ZALE V-P SHUNT CDS, Pack Number CDS983186I ; 62) ZALE V-P SHUNT CDS, Pack Number CDS983186J ; 63) VP SHUNT, Pack Number CDS983366J ; 64) VP SHUNT, Pack Number CDS983366M ; 65) VP SHUNT, Pack Number CDS983366N ; 66) VP SHUNT, Pack Number CDS983366P ; 67) NEURO CDS-LF, Pack Number CDS983383F ; 68) NEURO CDS-LF, Pack Number CDS983383G ; 69) NEURO CDS-LF, Pack Number CDS983383I ; 70) NEURO CDS-LF, Pack Number CDS983383J ; 71) AV SHUNT CDS, Pack Number CDS983792C ; 72) AV SHUNT CDS, Pack Number CDS983792D ; 73) ANTERIOR NEURO CDS, Pack Number CDS983882C ; 74) ANTERIOR NEURO CDS, Pack Number CDS983882D ; 75) POSTERIOR NEURO CDS , Pack Number CDS983885C ; 76) POSTERIOR NEURO CDS , Pack Number CDS983885D ; 77) POSTERIOR NEURO CDS , Pack Number CDS983885F ; 78) NEURO CDS , Pack Number CDS983981D ; 79) NEURO CDS , Pack Number CDS983981F ; 80) NEURO CDS , Pack Number CDS983981I ; 81) NEURO CDS , Pack Number CDS983981J ; 82) NEURO CDS , Pack Number CDS983981K ; 83) NEURO CDS , Pack Number CDS983981L ; 84) CRANI NEURO CDS , Pack Number CDS984172F ; 85) PUH NEURO EEA CDS , Pack Number CDS984297G ; 86) PUH NEURO VP SHUNT CDS, Pack Number CDS984323G ; 87) ME

Published September 18, 2024 · Recall initiated: April 8, 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

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Distributor: Worldwide distribution.
Lot: 00-401327AA, Lot Number 20AMA256 ; 00-401327AA, Lot Number 20AMC142 ; 00-401327AA, Lot Number 20BMB258 ; 00-401327AA, Lot Number 20DMB109 ; 00-401327AA, Lot Number 20GMB772 ; 00-401327AA, Lot Number 20HMC035 ; 00-401327AA, Lot Number 20JMA910 ; 00-401327AA, Lot Number 20JMB656 ; 00-401327AA, Lot Number 21CMA167 ; 00-401327AA, Lot Number 21EMB860 ; 00-401327AA, Lot Number 21FMC472 ; 00-401327AA, Lot Number 21GMF286 ; 00-401327AA, Lot Number 21HME693 ; 00-401327AA, Lot Number 21IMC842 ; 00-401327AA, Lot Number 21KMB315 ; 00-401594R , Lot Number 19LDA473 ; 00-401594R , Lot Number 20ADB972 ; 00-401594R , Lot Number 20CDC521 ; 00-401594R , Lot Number 20EDB836 ; 00-401594R , Lot Number 20HDA321 ; 00-401594R , Lot Number 21CDB556 ; 00-401594R , Lot Number 21EDA344 ; 00-401808S , Lot Number 21GBR684 ; 00-401808S , Lot Number 21IBB505 ; 00-401808S , Lot Number 21JBD593 ; 00-401808S , Lot Number 21JBD594 ; 00-401808S , Lot Number 21JBD596 ; 00-401808S , Lot Number 22ABS576 ; 00-401808S , Lot Number 19ABL630 ; 00-401808S , Lot Number 22NBA002 ; 00-401808S , Lot Number 19BBJ217 ; 00-401808S , Lot Number 22OBB643 ; 00-401808S , Lot Number 19DBK655 ; 00-401808S , Lot Number 22FBO951 ; 00-401808S , Lot Number 19FBI621 ; 00-401808S , Lot Number 19FBV633 ; 00-401808S , Lot Number 22HBR194 ; 00-401808S , Lot Number 22IBG899 ; 00-401808S , Lot Number 19HBL271 ; 00-401808S , Lot Number 22JBH625 ; 00-401808S , Lot Number 19IBG849 ; 00-401808S , Lot Number 22KBP137 ; 00-401808S , Lot Number 19IBZ700 ; 00-401808S , Lot Number 22LBN374 ; 00-401808S , Lot Number 19VBC278 ; 00-401808S , Lot Number 19KBQ992 ; 00-401808S , Lot Number 23CBC166 ; 00-401808S , Lot Number 19LBK455 ; 00-401808S , Lot Number 23CBW993 ; 00-401808S , Lot Number 23EBE204 ; 00-401808S , Lot Number 23EBF240 ; 00-401808S , Lot Number 20CBH056 ; 00-401808S , Lot Number 23GBN716 ; 00-401808S , Lot Number 20CBY951 ; 00-401808S , Lot Number 23HBG573 ; 00-401808S , Lot Number 20FBB585 ; 00-401808S , Lot Number 20FBE238 ; 00-401808S , Lot Number 20FBF231 ; 00-401808S , Lot Number 23JBC088 ; 00-401808S , Lot Number 20GBJ388 ; 00-401808S , Lot Number 23KBM084 ; 00-401808S , Lot Number 20JBC354 ; 00-401808S , Lot Number 20LBD734 ; 00-401808S , Lot Number 21CBX182 ; CDS780056K , Lot Number 19BBQ112 ; CDS780056K , Lot Number 19FBQ838 ; CDS780056K , Lot Number 19HBN954 ; CDS780056K , Lot Number 19JBJ354 ; CDS780056K , Lot Number 19KBF418 ; CDS780056K , Lot Number 20BBF089 ; CDS780056K , Lot Number 20OBA309 ; CDS780056K , Lot Number 20DBL328 ; CDS780056K , Lot Number 20GBL494 ; CDS780056K , Lot Number 20GBV115 ; CDS780056K , Lot Number 20KBS804 ; CDS780056K , Lot Number 20WBI356 ; CDS780056K , Lot Number 21DBU610 ; CDS780056L , Lot Number 21IBV394 ; CDS780056L , Lot Number 21KBG946 ; CDS780103K , Lot Number 22OBI238 ; CDS780103K , Lot Number 22FBF458 ; CDS780103K , Lot Number 22HBF971 ; CDS780103K , Lot Number 22HBF972 ; CDS780103K , Lot Number 22IBQ334 ; CDS780103K , Lot Number 22JBR855 ; CDS780103K , Lot Number 22LBB223 ; CDS780103K , Lot Number 23BBD147 ; CDS780103K , Lot Number 23FBQ301 ; CDS780103K , Lot Number 23GBE098 ; CDS780103K , Lot Number 23GBT769 ; CDS780103K , Lot Number 23IBB510 ; CDS780103K , Lot Number 23JBG685 ; CDS780103K , Lot Number 23LBR311 ; CDS780103K , Lot Number 23LBV808 ; CDS780103K , Lot Number 24CBE995 ; CDS780108T , Lot Number 19DLA065 ; CDS780108T , Lot Number 19DLA501 ; CDS780108T , Lot Number 19DLA665 ; CDS780108T , Lot Number 19FLA394 ; CDS780108T , Lot Number 19GLA142 ; CDS780108T , Lot Number 19GLA202 ; CDS780108T , Lot Number 19GLA261 ; CDS780108T , Lot Number 19HLA111 ; CDS780108T , Lot Number 19HLA402 ; CDS780108T , Lot Number 19ILA293 ; CDS780108T , Lot Number 19JLA050 ; CDS780108T , Lot Number 19JLA667 ; CDS780108T , Lot Number 19KLA463 ; CDS780108T , Lot Number 20ALA303 ; CDS780108T , Lot Number 20BLA407 ; CDS780109M , Lot Number 19CBI751 ; CDS7
Risk classification: Class II
Area (FDA): device
Country: United States

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