FDAFDA · Food and drugs·Recall number Z-3016-2024
Medline Convenience kits labeled as: 1) CHEST EXPLORATION CDS , Pack Number CDS920066K ; 2) CHEST EXPLORATION CDS , Pack Number CDS920066L ; 3) PLASTIC SMR CDS-LF, Pack Number CDS980088K ; 4) PLASTICS, Pack Number CDS980200AA; 5) PLASTICS, Pack Number CDS980200Y ; 6) BREAST/MINOR, Pack Number CDS980228W ; 7) PLASTIC CDS , Pack Number CDS980232U ; 8) PLASTIC CDS , Pack Number CDS980232V ; 9) PLASTIC CDS , Pack Number CDS980232W ; 10) PLASTIC CDS , Pack Number CDS980232X ; 11) LTP CDS-LF, Pack Number CDS980375L ; 12) PLASTIC CDS , Pack Number CDS980457R ; 13) PLASTIC CDS , Pack Number CDS980457S ; 14) PLASTIC CDS , Pack Number CDS980457T ; 15) BREAST AUG, Pack Number CDS980567R ; 16) BREAST AUG, Pack Number CDS980567S ; 17) LARGE PROCEDURE-LF, Pack Number CDS981257J ; 18) LARGE PROCEDURE-LF, Pack Number CDS981257K ; 19) BREAST CDS, Pack Number CDS981691N ; 20) MAJOR PLASTICS CDS, Pack Number CDS981958I ; 21) MAJOR PLASTIC CDS-LF, Pack Number CDS981978J ; 22) MINOR PLASTIC , Pack Number CDS982018K ; 23) MAJOR BREAST, Pack Number CDS982038S ; 24) VASAL RECONSTRUCTION, Pack Number CDS982042O ; 25) MINOR BREAST, Pack Number CDS982053M ; 26) MINOR BREAST, Pack Number CDS982053N ; 27) MINOR BREAST, Pack Number CDS982053O ; 28) MINOR BREAST, Pack Number CDS982053P ; 29) BREAST AUGMENTATION , Pack Number CDS982254K ; 30) BREAST AUGMENTATION , Pack Number CDS982254L ; 31) BREAST AUGMENTATION , Pack Number CDS982254M ; 32) BREAST REDUCTION CDS, Pack Number CDS982255G ; 33) BREAST REDUCTION CDS, Pack Number CDS982255I ; 34) BREAST REDUCTION, Pack Number CDS982255J ; 35) TYMPANOPLASTY , Pack Number CDS982720M ; 36) MAJOR BREAST CDS SJF-LF , Pack Number CDS982730M ; 37) REDUCTION CDS , Pack Number CDS982776J ; 38) REDUCTION CDS , Pack Number CDS982776K ; 39) REDUCTION CDS , Pack Number CDS982776L ; 40) HMT MAJOR BREAST/PLASTICS CDS , Pack Number CDS982860R ; 41) MAG PLASTIC CDS , Pack Number CDS982909I ; 42) MAG PLASTIC CDS , Pack Number CDS982909J ; 43) MAG PLASTIC CDS , Pack Number CDS982909K ; 44) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910K ; 45) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910L ; 46) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910M ; 47) MAG FREE FLAP CDS-LF, Pack Number CDS982911K ; 48) GENERAL BREAST, Pack Number CDS983058G ; 49) GENERAL BREAST, Pack Number CDS983058I ; 50) BASIC PLASTIC CDS-LF, Pack Number CDS983141C ; 51) BASIC PLASTIC CDS-LF, Pack Number CDS983141D ; 52) BREAST CDS, Pack Number CDS983148A ; 53) BREAST CDS, Pack Number CDS983148B ; 54) ZALE STEREOTACTIC CDS , Pack Number CDS983173I ; 55) CUH ABDOMINOPLASTY CDS, Pack Number CDS983176I ; 56) MAJOR CDS , Pack Number CDS983292D ; 57) PECTUS REPAIR , Pack Number CDS983353R ; 58) PECTUS REPAIR , Pack Number CDS983353S ; 59) PECTUS REPAIR , Pack Number CDS983353T ; 60) PECTUS REPAIR , Pack Number CDS983353U ; 61) PECTUS REPAIR , Pack Number CDS983353V ; 62) PECTUS REPAIR , Pack Number CDS983353X ; 63) MAMMOPLASTY-LF, Pack Number CDS983478J ; 64) MAMMOPLASTY-LF, Pack Number CDS983478K ; 65) MAMMOPLASTY-LF, Pack Number CDS983478L ; 66) PLASTICS FREE FLAP, Pack Number CDS983493L; 67) PLASTICS FREE FLAP, Pack Number CDS983493M; 68) PLASTIC TORSO-LF, Pack Number CDS983496I ; 69) PLASTIC TORSO-LF, Pack Number CDS983496J ; 70) PLASTIC TORSO-LF, Pack Number CDS983496K ; 71) PLASTIC TORSO-LF, Pack Number CDS983496L ; 72) PLASTIC HEAD AND NECK-LF, Pack Number CDS983498I ; 73) PLASTIC HEAD AND NECK-LF, Pack Number CDS983498J ; 74) ACH PLASTICS BREAST-LF, Pack Number CDS983639C ; 75) ACH PLASTICS BREAST-LF, Pack Number CDS983639D ; 76) ACH PLASTICS BREAST-LF, Pack Number CDS983639G ; 77) ACH PLASTICS BREAST-LF, Pack Number CDS983639I ; 78) ACH PLASTICS BREAST-LF, Pack Number CDS983639J ; 79) ACH PLASTICS BREAST-LF, Pack Number CDS983639K ; 80) NE BREAST AUGMENTATION CDS, Pack Number CDS983660C ; 81) NE BREAST RECON CDS , Pack Number CDS983660D ; 82) NE BREAST RECON
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
- CDS920066K , Lot Number 19ABM835 ; CDS920066K , Lot Number 19CBD966 ; CDS920066K , Lot Number 19DBS028 ; CDS920066L , Lot Number 19FBR839 ; CDS920066L , Lot Number 20DBM938 ; CDS920066L , Lot Number 20GBG553 ; CDS920066L , Lot Number 20IBF930 ; CDS920066L , Lot Number 20IBL798 ; CDS980088K , Lot Number 19ABF841 ; CDS980088K , Lot Number 19BBR779 ; CDS980088K , Lot Number 19CBI036 ; CDS980088K , Lot Number 19EBY389 ; CDS980088K , Lot Number 19HBO214 ; CDS980088K , Lot Number 19HBU649 ; CDS980088K , Lot Number 19IBX782 ; CDS980200AA, Lot Number 21HBO940 ; CDS980200AA, Lot Number 21KBH187 ; CDS980200AA, Lot Number 22ABI736 ; CDS980200AA, Lot Number 22EBS477 ; CDS980200AA, Lot Number 22FBE877 ; CDS980200AA, Lot Number 22FBG077 ; CDS980200AA, Lot Number 22GBA222 ; CDS980200AA, Lot Number 22HBL578 ; CDS980200AA, Lot Number 22HBN078 ; CDS980200AA, Lot Number 22IBD419 ; CDS980200AA, Lot Number 22JBQ932 ; CDS980200AA, Lot Number 22KBJ570 ; CDS980200AA, Lot Number 22KBM262 ; CDS980200AA, Lot Number 23ABN721 ; CDS980200AA, Lot Number 23CBD776 ; CDS980200AA, Lot Number 23EBD623 ; CDS980200AA, Lot Number 23EBK657 ; CDS980200AA, Lot Number 23HBK655 ; CDS980200AA, Lot Number 23IBU758 ; CDS980200AA, Lot Number 23JBJ092 ; CDS980200AA, Lot Number 23KBA249 ; CDS980200AA, Lot Number 24ABV345 ; CDS980200AA, Lot Number 21CBF899 ; CDS980200AA, Lot Number 21EBO710 ; CDS980200Y , Lot Number 19ABR558 ; CDS980200Y , Lot Number 19DBG664 ; CDS980200Y , Lot Number 19FBZ748 ; CDS980200Y , Lot Number 19HBB367 ; CDS980200Y , Lot Number 19TBB908 ; CDS980200Y , Lot Number 19JBC014 ; CDS980200Y , Lot Number 19KBN743 ; CDS980200Y , Lot Number 20BBE167 ; CDS980200Y , Lot Number 20DBH152 ; CDS980200Y , Lot Number 20FBR880 ; CDS980200Y , Lot Number 20HBE774 ; CDS980200Y , Lot Number 20IBG766 ; CDS980200Y , Lot Number 20JBR282 ; CDS980200Y , Lot Number 20LBQ487 ; CDS980200Y , Lot Number 21ABC248 ; CDS980228W , Lot Number 19ABW907 ; CDS980228W , Lot Number 19BBL561 ; CDS980228W , Lot Number 19CBM174 ; CDS980228W , Lot Number 19EBN810 ; CDS980228W , Lot Number 19FBN128 ; CDS980228W , Lot Number 19HBH107 ; CDS980228W , Lot Number 19HBX070 ; CDS980228W , Lot Number 19JBA329 ; CDS980228W , Lot Number 19KBH852 ; CDS980228W , Lot Number 19LBR795 ; CDS980228W , Lot Number 20BBQ462 ; CDS980228W , Lot Number 20BBZ179 ; CDS980228W , Lot Number 20EBI895 ; CDS980228W , Lot Number 20FBK517 ; CDS980228W , Lot Number 20GBR042 ; CDS980228W , Lot Number 20IBI018 ; CDS980228W , Lot Number 20JBR049 ; CDS980228W , Lot Number 20KBT175 ; CDS980228W , Lot Number 21ABC714 ; CDS980228W , Lot Number 21BBG051 ; CDS980228W , Lot Number 21CBU644 ; CDS980228W , Lot Number 21EBH357 ; CDS980232U , Lot Number 19BBH968 ; CDS980232U , Lot Number 19CBK976 ; CDS980232U , Lot Number 19EBU029 ; CDS980232U , Lot Number 19FBS139 ; CDS980232U , Lot Number 19GBW172 ; CDS980232U , Lot Number 19HBM330 ; CDS980232U , Lot Number 19VBF307 ; CDS980232U , Lot Number 19LBK396 ; CDS980232V , Lot Number 19KBR773 ; CDS980232V , Lot Number 20ABF339 ; CDS980232V , Lot Number 20BBB986 ; CDS980232V , Lot Number 20BBU668 ; CDS980232V , Lot Number 20CBR984 ; CDS980232V , Lot Number 20CBW496 ; CDS980232V , Lot Number 20DBL307 ; CDS980232V , Lot Number 20EBO737 ; CDS980232V , Lot Number 20FBF081 ; CDS980232V , Lot Number 20GBB769 ; CDS980232V , Lot Number 20HBE599 ; CDS980232V , Lot Number 20IBF392 ; CDS980232V , Lot Number 20IBR161 ; CDS980232V , Lot Number 20KBB632 ; CDS980232V , Lot Number 20LBS158 ; CDS980232V , Lot Number 21BBD337 ; CDS980232V , Lot Number 21BBF806 ; CDS980232V , Lot Number 21CBT360 ; CDS980232V , Lot Number 21DBC544 ; CDS980232V , Lot Number 21EBI364 ; CDS980232W , Lot Number 21IBL710 ; CDS980232W , Lot Number 21IBP897 ; CDS980232W , Lot Number 21IBP933 ; CDS980232W , Lot Number 22CBT696 ; CDS980232W , Lot Number 22DBM998 ; CDS980232W , Lot Number 22EBA374 ; CDS980232W , Lot Number 22FBM675 ; CDS9
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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