FDAFDA · Alimentos y medicamentos·N.º oficial Z-3045-2024
Medline Convenience kits labeled as: 1) GROTH PELVISCOPY CDS, Pack Number CDS984187T ; 2) GROTH PELVISCOPY, Pack Number CDS984187U ; 3) DERMATOLOGY KIT, Pack Number DYNDA1567D; 4) ER MINOR SUTURE SET, Pack Number DYNDA1977A; 5) HSG TRAY, Pack Number DYNDH1453; 6) TRAY, ER LACERATION, Pack Number DYNDL1569A; 7) LAP/PELVISCOPY CSTM PK-LF , Pack Number DYNJ0157511K ; 8) SMSC-PELVISCOPY PACK-LF , Pack Number DYNJ0161619I ; 9) LAPAROSCOPY/PELVISCOPY PACK-LF, Pack Number DYNJ0477038K ; 10) LITHOTOMY/PELVISCOPY PACK , Pack Number DYNJ0531985R ; 11) GYN PELVISCOPY PACK-LF, Pack Number DYNJ0537705L ; 12) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009W ; 13) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009Y ; 14) PELVISCOPY PACK-LF, Pack Number DYNJ0843760I ; 15) PELVISCOPY PACK-LF, Pack Number DYNJ0843760J ; 16) PELVISCOPY LAP-LF , Pack Number DYNJ40099B ; 17) PELVISCOPY LAP-LF , Pack Number DYNJ40099C ; 18) PELVISCOPY GYN LAP PACK , Pack Number DYNJ40608D ; 19) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595N ; 20) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595O ; 21) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595P ; 22) RFLAP PELVISCOPY PCK(LPLUH)-LF, Pack Number DYNJ47703G ; 23) PELVISCOPY PACK , Pack Number DYNJ50688D ; 24) PELVISCOPY PACK , Pack Number DYNJ50688F ; 25) HHI LITHOTOMY PELVISCOPY PACK , Pack Number DYNJ51918D ; 26) PELVIC LAP, Pack Number DYNJ53601G ; 27) VAGINAL PACK, Pack Number DYNJ59786B ; 28) PELVIC PACK , Pack Number DYNJ63057D ; 29) PELVIC PACK , Pack Number DYNJ63057F ; 30) PERI GYN, Pack Number DYNJ64239B ; 31) OB GYN PACK , Pack Number DYNJ80831; 32) MON OB GYN PACK , Pack Number DYNJ80831A ; 33) MON OB GYN PACK , Pack Number DYNJ80831B ; 34) LAP PELVISCOPY PACK , Pack Number DYNJ82449; 35) PELVISCOPY PACK , Pack Number DYNJ82555; 36) PELVISCOPY PACK , Pack Number DYNJ82555A ; 37) PELVISCOPY, Pack Number DYNJ82676; 38) PERIPELVIC PACK , Pack Number DYNJ83912; 39) PELVISCOPY PACK , Pack Number DYNJ84379; 40) PELVISCOPY PACK , Pack Number DYNJ85311; 41) D-PELVISCOPY, Pack Number DYNJ900628I; 42) PELVISCOPY, Pack Number DYNJ901655F; 43) PELVISCOPY, Pack Number DYNJ901655G; 44) PELVISCOPY, Pack Number DYNJ908446B; 45) NILES LAP PELVIC-LF , Pack Number DYNJ908459A; 46) NILES LAP PELVIC RFID-LF, Pack Number DYNJ908459B
Publicado el 18 de septiembre de 2024 · Inicio del retiro: 8 de abril 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
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.
Qué hacer
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Detalles del retiro
- Fabricante
- MEDLINE INDUSTRIES, LP - Northfield
- Distribuidor
- Worldwide distribution.
- Lote
- CDS984187T , Lot Number 22JBX647 ; CDS984187T , Lot Number 22KBH092 ; CDS984187T , Lot Number 22KBN639 ; CDS984187T , Lot Number 23ABJ847 ; CDS984187T , Lot Number 23DBN636 ; CDS984187T , Lot Number 23EBN741 ; CDS984187T , Lot Number 23FBO660 ; CDS984187U , Lot Number 23GBV733 ; CDS984187U , Lot Number 23HBA604 ; CDS984187U , Lot Number 23JBE143 ; CDS984187U , Lot Number 23JBE436 ; CDS984187U , Lot Number 23JBX523 ; CDS984187U , Lot Number 23LBN764 ; CDS984187U , Lot Number 24BBN238 ; CDS984187U , Lot Number 24BBU609 ; DYNDA1567D, Lot Number 2019071090; DYNDA1977A, Lot Number 2019071090; DYNDH1453, Lot Number 2019071090; DYNDL1569A, Lot Number 2019071090; DYNJ0157511K , Lot Number 23LMI154 ; DYNJ0161619I , Lot Number 23EMI816 ; DYNJ0161619I , Lot Number 23FMC245 ; DYNJ0161619I , Lot Number 23FMI370 ; DYNJ0161619I , Lot Number 23HMB229 ; DYNJ0161619I , Lot Number 23KMC793 ; DYNJ0161619I , Lot Number 23KMF807 ; DYNJ0477038K , Lot Number 23CBW969 ; DYNJ0477038K , Lot Number 23EBW988 ; DYNJ0477038K , Lot Number 23HBA845 ; DYNJ0477038K , Lot Number 23IBP147 ; DYNJ0477038K , Lot Number 23LBE881 ; DYNJ0531985R , Lot Number 22HMF853 ; DYNJ0531985R , Lot Number 22LMG691 ; DYNJ0531985R , Lot Number 23AMF501 ; DYNJ0531985R , Lot Number 23CMA603 ; DYNJ0531985R , Lot Number 23DMG508 ; DYNJ0537705L , Lot Number 23FMG696 ; DYNJ0537705L , Lot Number 23IMC689 ; DYNJ0780009W , Lot Number 22HMF696 ; DYNJ0780009W , Lot Number 22JME002 ; DYNJ0780009Y , Lot Number 23EMB610 ; DYNJ0780009Y , Lot Number 23EMI825 ; DYNJ0780009Y , Lot Number 23FMA234 ; DYNJ0780009Y , Lot Number 23HMC653 ; DYNJ0780009Y , Lot Number 23JMB180 ; DYNJ0780009Y , Lot Number 23JMI648 ; DYNJ0843760I , Lot Number 23DDA645 ; DYNJ0843760I , Lot Number 23EDA680 ; DYNJ0843760J , Lot Number 23JDA821 ; DYNJ40099B , Lot Number 22ABP008 ; DYNJ40099B , Lot Number 22BBW136 ; DYNJ40099C , Lot Number 22FMB339 ; DYNJ40099C , Lot Number 22HMA727 ; DYNJ40099C , Lot Number 22IMG228 ; DYNJ40099C , Lot Number 23BMG958 ; DYNJ40099C , Lot Number 23BMH600 ; DYNJ40099C , Lot Number 23DMD083 ; DYNJ40099C , Lot Number 23DMG556 ; DYNJ40099C , Lot Number 23FMJ765 ; DYNJ40099C , Lot Number 23IMG857 ; DYNJ40099C , Lot Number 23KMJ168 ; DYNJ40099C , Lot Number 23LME309 ; DYNJ40608D , Lot Number 23GBL162 ; DYNJ40608D , Lot Number 23HBP723 ; DYNJ40608D , Lot Number 23KBF077 ; DYNJ40608D , Lot Number 23LBF535 ; DYNJ47595N , Lot Number 23CMD083 ; DYNJ47595O , Lot Number 23FMF971 ; DYNJ47595P , Lot Number 23JMC128 ; DYNJ47703G , Lot Number 23HME411 ; DYNJ50688D , Lot Number 21HMG928 ; DYNJ50688D , Lot Number 21HMH101 ; DYNJ50688D , Lot Number 22AMG373 ; DYNJ50688F , Lot Number 22HMH924 ; DYNJ50688F , Lot Number 22KMC285 ; DYNJ50688F , Lot Number 23EMA056 ; DYNJ50688F , Lot Number 23GMF859 ; DYNJ51918D , Lot Number 22IMA468 ; DYNJ51918D , Lot Number 22KMB312 ; DYNJ51918D , Lot Number 23AMA366 ; DYNJ51918D , Lot Number 23DMG134 ; DYNJ51918D , Lot Number 23HMI850 ; DYNJ51918D , Lot Number 23IMC261 ; DYNJ53601G , Lot Number 23HME948 ; DYNJ53601G , Lot Number 23KMG377 ; DYNJ59786B , Lot Number 21KMB136 ; DYNJ59786B , Lot Number 22AME269 ; DYNJ59786B , Lot Number 22DMF348 ; DYNJ59786B , Lot Number 22EMF415 ; DYNJ59786B , Lot Number 22FMB585 ; DYNJ59786B , Lot Number 22GMG722 ; DYNJ59786B , Lot Number 22IMG806 ; DYNJ59786B , Lot Number 23AMH416 ; DYNJ59786B , Lot Number 23DMC700 ; DYNJ59786B , Lot Number 23EMF594 ; DYNJ59786B , Lot Number 23EMK224 ; DYNJ59786B , Lot Number 23FMD759 ; DYNJ59786B , Lot Number 23FMI823 ; DYNJ59786B , Lot Number 23GMG644 ; DYNJ59786B , Lot Number 23JMG306 ; DYNJ63057D , Lot Number 22HMB872 ; DYNJ63057D , Lot Number 22JMC857 ; DYNJ63057D , Lot Number 22KMD431 ; DYNJ63057D , Lot Number 23CMC877 ; DYNJ63057D , Lot Number 23EMB169 ; DYNJ63057D , Lot Number 23GMF137 ; DYNJ63057D , Lot Number 23HME622 ; DYNJ63057D , Lot Number 23HMH140 ; DYNJ63057F , Lot Number 23JMB899 ; DYNJ64239B , Lot
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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