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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2765-2024

Medline procedural kits labeled as: 1) AFCH ANTERIOR SEGMENT PK, Pack Number DYNJ63330B ; 2) ANTERIOR HIP PACK , Pack Number DYNJ82317; 3) ARTHROGRAM, Pack Number DYNDH1446A ; 4) ARTHROGRAM TRAY, Pack Number DYNDH1648; 5) ARTHROGRAM TRAY, Pack Number PAIN1396 ; 6) ARTHROGRAM TRAY , Pack Number DYNDH1648; 7) ARTHROGRAM TRAY , Pack Number PAIN1396 ; 8) ARTHROGRAM/ASPIRATION RADIOLOG, Pack Number DYNJRA2152 ; 9) ARTHROGRAPH TRAY, Pack Number MNS12670B; 10) ARTHROSCOPY , Pack Number DYNJ909699 ; 11) GLMI ARTHROGRAM KIT: BIG TREE , Pack Number DYNDH1752; 12) HANA TABLE, Pack Number DYNJ908424A; 13) JC HIP ARTHROSCOPY, Pack Number DYNJ907481 ; 14) JC KNEE ARTHROSCOPY , Pack Number DYNJ907480 ; 15) JC KNEE ARTHROSCOPY , Pack Number DYNJ907480A; 16) JC SHOULDER ARTHROSCOPY , Pack Number DYNJ907479A; 17) LUMBAR DRAIN PACK , Pack Number DYNJ67379; 18) LUMBAR DRAIN PACK , Pack Number DYNJ67379H ; 19) OPEN SHOULDER CDS , Pack Number CDS983316D ; 20) ORTHO SPINE PACK, Pack Number DYNJ59720A ; 21) ORTHO SPINE PACK, Pack Number DYNJ59720B ; 22) PODIATRY TRAY-LF, Pack Number DYNJ51178D ; 23) TOTAL KNEE CDS-LF , Pack Number CDS940845L ; 24) TOTAL KNEE CDS-LF , Pack Number DYNJ907028 ; 25) TOTAL KNEE CDS-LF , Pack Number DYNJ907028A; 26) TOTAL KNEE CDS-LF , Pack Number DYNJ907028C

Publicado el 4 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
Lote
DYNJ63330B , Lot Number: 23KMB339 ; DYNJ82317, Lot Number: 23JMD184 ; DYNDH1446A , Lot Number: 21LBY820 ; DYNDH1446A , Lot Number: 22GBD333 ; DYNDH1446A , Lot Number: 22JBR587 ; DYNDH1446A , Lot Number: 23FBP838 ; DYNDH1446A , Lot Number: 23GBR825 ; DYNDH1446A , Lot Number: 23HBU128 ; DYNDH1446A , Lot Number: 23IBD510 ; DYNDH1446A , Lot Number: 23JBY402 ; DYNDH1446A , Lot Number: 24ABN001 ; DYNDH1446A , Lot Number: 24BBU148 ; DYNDH1446A , Lot Number: 21BBP451 ; DYNDH1446A , Lot Number: 21BBQ361 ; DYNDH1648, Lot Number: 24CBI888 ; PAIN1396 , Lot Number: 24CMC928 ; DYNDH1648, Lot Number: 23BBU844 ; DYNDH1648, Lot Number: 23FBT610 ; DYNDH1648, Lot Number: 23KBG110 ; DYNDH1648, Lot Number: 23LBH307 ; DYNDH1648, Lot Number: 24BBQ373 ; PAIN1396 , Lot Number: 21HBQ984 ; PAIN1396 , Lot Number: 21LBQ751 ; PAIN1396 , Lot Number: 22BBY990 ; PAIN1396 , Lot Number: 22EBO906 ; PAIN1396 , Lot Number: 22GMH098 ; PAIN1396 , Lot Number: 22JMC249 ; PAIN1396 , Lot Number: 23AMC516 ; DYNJRA2152 , Lot Number: 23FBO275 ; DYNJRA2152 , Lot Number: 24BBP039 ; MNS12670B, Lot Number: 21FBO557 ; DYNJ909699 , Lot Number: 23IBG223 ; DYNJ909699 , Lot Number: 23IBI956 ; DYNDH1752, Lot Number: 22HLA308 ; DYNDH1752, Lot Number: 22KLA526 ; DYNDH1752, Lot Number: 23ELA116 ; DYNDH1752, Lot Number: 23FLA891 ; DYNDH1752, Lot Number: 23HLA148 ; DYNDH1752, Lot Number: 23JLA566 ; DYNJ908424A, Lot Number: 23IBP270 ; DYNJ907481 , Lot Number: 22CBZ144 ; DYNJ907481 , Lot Number: 22JBR781 ; DYNJ907480 , Lot Number: 21LBR978 ; DYNJ907480A, Lot Number: 22GBS401 ; DYNJ907480A, Lot Number: 22HBS464 ; DYNJ907480A, Lot Number: 22KBO665 ; DYNJ907480A, Lot Number: 22LBM801 ; DYNJ907480A, Lot Number: 23ABS425 ; DYNJ907480A, Lot Number: 23BBN787 ; DYNJ907480A, Lot Number: 23JBR354 ; DYNJ907480A, Lot Number: 24ABJ482 ; DYNJ907479A, Lot Number: 22EBM144 ; DYNJ907479A, Lot Number: 22EBN033 ; DYNJ67379, Lot Number: 22OBA461 ; DYNJ67379H , Lot Number: 22OBA461 ; CDS983316D , Lot Number: 21KBZ646 ; CDS983316D , Lot Number: 22GBK913 ; CDS983316D , Lot Number: 22JBP359 ; CDS983316D , Lot Number: 22JBQ356 ; DYNJ59720A , Lot Number: 21LBL971 ; DYNJ59720B , Lot Number: 22GBE154 ; DYNJ59720B , Lot Number: 22HBY469 ; DYNJ59720B , Lot Number: 23FBQ399 ; DYNJ59720B , Lot Number: 23IBL648 ; DYNJ51178D , Lot Number: 23IDA216 ; CDS940845L , Lot Number: 21LBG348 ; CDS940845L , Lot Number: 22GBJ055 ; CDS940845L , Lot Number: 22GBJ056 ; CDS940845L , Lot Number: 22KBH989 ; CDS940845L , Lot Number: 22KBJ721 ; CDS940845L , Lot Number: 22KBJ722 ; DYNJ907028 , Lot Number: 21KBV769 ; DYNJ907028 , Lot Number: 21LBG283 ; DYNJ907028A, Lot Number: 22HBS848 ; DYNJ907028C, Lot Number: 23BBN541 ; DYNJ907028C, Lot Number: 23CBO748 ; DYNJ907028C, Lot Number: 23GBC293 ; DYNJ907028C, Lot Number: 23IBD257 ; DYNJ907028C, Lot Number: 23IBV462
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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