Retiro De Equipo (Recall) de Device Recall 1 Liter LatexFree Breathing Bag

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Medline Industries Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Reservoir Bag - Product Code BTC
  • Causa
    Separation from bushing: the breathing bag may separate from the bushing during use.
  • Acción
    Consignees were notified by a Sub-Recall Notice letter sent on 12/5/07. The letter instructed users to check their inventory for any affected product and to return a response card indicating the quantity of affected product. The users were instructed to return the affected products to the recalling firm so that they can be reworked. Users who did not wish to return the affected products could request a replacement product and were instructed to destroy the affected products. The letter also informed users that affected products in the manufacturer's inventory were being replaced and these replaced products would contain the label "INSPECTED." For additional information, contact 1-866-359-1704.


  • Modelo / Serial
    1 liter bag, Vendor Part Number: 720059B, Medline Item Number: 40056, all lots manufactured after October 2006, packaged in the following kits:  1) Item Number: CDS980230I, Lot Numbers: 07JB0905; 2) Item Number: DYNJ22691, Lot Number: 07HD1853; 3) Item Number: DYNJ24724, Lot Number: 07KB5026; 4) Item Number: DYNJAAHY11, Lot Number: 07HD3686; 5) Item Number: DYNJAP0010, Lot Number: 07KD3028; 6) Item Number: DYNJAP0011A, Lot Numbers: 07HD4225, 07JD4412 and 07KD0167; 7) Item Number: DYNJAP0012, Lot Numbers: 07JD3974 and 07KD2230; 8) Item Number: DYNJAP0100, Lot Numbers: 07ID1739, 07ID3570 and 07JD2943; 9) Item Number: DYNJAP0101, Lot Number: 07ID2242; 10) Item Number: DYNJAP4012, Lot Numbers: 07ID1545, 07JD2944 and 07JD3987; 11) Item Number: DYNJAP4013, Lot Number: 07ID1524; 12) Item Number: DYNJAP4702A, Lot Number: 07HD3333; 13) Item Number: DYNJAP4707, Lot Numbers: 06LD3453, 07HD2988 and 07JD3927; 14) Item Number: DYNJAP4722, Lot Number: 07ID2432; 15) Item Number: DYNJAP4729A, Lot Numbers: 07ID4021 and 07JD4476; 16) Item Number: DYNJAP4730A, Lot Number: 07HD3649; 17) Item Number: DYNJAP4732, Lot Numbers: 07ED4394 and 07KB1986; 18) Item Number: DYNJAP4740, Lot Numbers: 07ID0168, 07ID2021, 07ID4063, 07JD1340 and 07JD4573; 19) Item Number: DYNJAP6101, Lot Number: 07JD1161; 20) Item Number: DYNJAP6105, Lot Numbers: 07ID0137 and 07KD2092; 21) Item Number: DYNJAP6106, Lot Number: 07KD0278; 22) Item Number: DYNJAP6107, Lot Number: 07JD0779; 23) Item Number: DYNJAP6108, Lot Numbers: 07ID0135 and 07JD0018; 24) Item Number: DYNJAP6109, Lot Numbers: 07HD4400, 07JD0205 and 07KD2228; 25) Item Number: DYNJAP6111, Lot Numbers: 07ID1373 and 07KB4359; 26) Item Number: DYNJAP6112, Lot Number: 07ID1546; 27) Item Number: DYNJAP6113, Lot Number: 07HD4394; 28) Item Number: DYNJAP6114, Lot Numbers: 07HD3332 and 07KD0567; 29) Item Number: DYNJAP6116, Lot Number: 07ID2441; 30) Item Number: DYNJAP6120A, Lot Number: 07ID1521; 31) Item Number: DYNJAP6124, Lot Numbers: 07HD3288, 07JD0019 and 07KD0358; 32) Item Number: DYNJAP6127, Lot Number: 07ID2266; 33) Item Number: DYNJAP6130, Lot Numbers: 07HD3650 and 07KD0363; 34) Item Number: DYNJAP6132A, Lot Number: 07JD0020; 35) Item Number: DYNJAP6133, Lot Number: 07JD0206; 36) Item Number: DYNJAP6136, Lot Number: 07KD1036; 37) Item Number: DYNJAP6137, Lot Number: 07GD2133; 38) Item Number: DYNJAP7217A, Lot Numbers: 07CD3854 and 07DD3017; 39) Item Number: DYNJAP7225A, Lot Numbers: 07GD1534 and 07HD3562; 40) Item Number: DYNJAP7227, Lot Number: 07JD1538; 41) Item Number: DYNJAP7233, Lot Numbers: 07CD0839 and 07ED0027; 42) Item Number: DYNJAP7234A, Lot Numbers: 07HD3459 and 07ID2630; 43) Item Number: DYNJAP7235A, Lot Number: 07ID2244; 44) Item Number: DYNJAP7236A, Lot Numbers: 07HD1578 and 07ID0169; 45) Item Number: DYNJAP7237, Lot Numbers: 06KD0647, 06LD3890, 07BD0978, 07BD3099, 07CD3597, 07DD3536, 07GD3218, 07HD3876, 07JD1158 and 07JD3969; 46) Item Number: DYNJAP7241A, Lot Number: 07HD3110; 47) Item Number: DYNJAP7243B, Lot Numbers: 07DD3540, 07ED4104, 07GD1839 and 07JD1190; 48) Item Number: DYNJAP7246C, Lot Numbers: 07IB2772 and 07JD0023; 49) Item Number: DYNJAP7247, Lot Number: 07JD1541; 50) Item Number: DYNJAP7248, Lot Number: 07KD1275; 51) Item Number: DYNJAP7261, Lot Numbers: 07HD2917, 07ID3527 and 07JD2945; 52) Item Number: DYNJAP7262, Lot Number: 07HD3564; 53) Item Number: DYNJAP7263, Lot Number: 07ID0954; 54) Item Number: DYNJAP9005, Lot Number: 07HD1253; 55) Item Number: DYNJAP9721A, Lot Numbers: 07ID2017 and 07KD2298; 56) Item Number: DYNJAP9725, Lot Number: 07JB3948; 57) Item Number: DYNJAP9726, Lot Number: 07HD2409; 58) Item Number: DYNJAP9729, Lot Number: 07JD2946; 59) Item Number: DYNJAP9730A, Lot Number: 07ID1106; 60) Item Number: DYNJAP9732A, Lot Numbers: 07CD1687, 07ED0308, 07GD2552, 07HD2648, 07JD0024 and 07KD2223; 61) Item Number: DYNJAP9735, Lot Number: 07DD4279; 62) Item Number: DYNJAP9739, Lot Numbers: 07DD0014 and 07DD3537; 63) Item Number: DYNJAP9740, Lot Number: 07DD1134; 64) Item Number: DYNJAP9743, Lot Numbers: 07ID0387, 07ID1751, 07JD1148, 07KD0651 and 07KD1360; 65) Item Number: DYNJAPF6003, Lot Numbers: 07CD1292, 07DD2344, 07ED0732, 07GD3088 and 07HD1080; 66) Item Number: DYNJAPF6005A, Lot Number: 07ID1348; 67) Item Number: DYNJAPF6006, Lot Numbers: 07HD2210 and 07ID2019; 68) Item Number: DYNJAPF6009, Lot Numbers: 07ID2076 and 07JD3978; 69) Item Number: DYNJAPF6011, Lot Number: 07HD4155; 70) Item Number: DYNJAPF6013, Lot Numbers: 07ED3128, 07GD1327 and 07ID1374; 71) Item Number: DYNJAPF6014, Lot Number: 07ID0924; 72) Item Number: DYNJQ9160A, Lot Numbers: 07BB1382, 07CB0600 and 07CB2528
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    1 Liter Latex-Free Breathing Bags; Reservoir Bag; Vendor Part Number: 720059B, Medline Item Number: 40056; Available in various Anesthesia Circuit Kits and Complete Delivery System kits including: 1) Item Number CDS980230I, NICU-OR CDS; 2) Item Number DYNJ22691, Basin Supply Pack; 3) Item Number DYNJ24724, Spine-Crani Anesthesia Kit; 4) Item Number DYNJAAHY11, Hyperinflation System-UHS-1L; 5) Item Number DYNJAP0010, Anesthesia Circuit Ped-LF; 6) Item Number DYNJAP0011A, Pediatric Circuit-LF; 7) Item Number DYNJAP0012, Pediatric Anesthesia 40 In. CI; 8) Item Number DYNJAP0100, Pedi Breathing Circuit-LF; 9) Item Number DYNJAP0101, Anesthesia Circuit-Ped; 10) Item Number DYNJAP4012, Anesthesia Circuit Ped; 11) Item Number DYNJAP4013, Anesthesia Circuit; 12) Item Number DYNJAP4702A, Anesth Circuit Ped GS Line; 13) Item Number DYNJAP4707, Anesth Circuit 40in Ped-LF; 14) Item Number DYNJAP4722, Anes Cir 40 Ped GSEPW HYBABYH; 15) Item Number DYNJAP4729A, Circ Ped Anes Super-LF; 16) Item Number DYNJAP4730A, Circuit Pediatric Anesthesia; 17) Item Number DYNJAP4732, Anesth Circ Ped 40in 2B/V; 18) Item Number DYNJAP4740, Anesth Circ 40in Ped; 19) Item Number DYNJAP6101, Anesthesia Circuit; 20) Item Number DYNJAP6105, Anesth Circuit 60in Ped; 21) Item Number DYNJAP6106, Anes Circ Ped 60in BI GSE-LF; 22) Item Number DYNJAP6107, Anesth Circ Ped 60in ANG HME; 23) Item Number DYNJAP6108, Anesth Circuit 60in Ped; 24) Item Number DYNJAP6109, Anesth Circ Ped 60in B/V 1L-LF; 25) Item Number DYNJAP6111, Anes Cir Ped 60 GSEPW PALL FIL; 26) Item Number DYNJAP6112, Anesthesia-Peds Circuit; 27) Item Number DYNJAP6113, Circuit Pedi 60in; 28) Item Number DYNJAP6114, Anesth Circ 60in Ped; 29) Item Number DYNJAP6116, Anesth Circ 60in Ped; 30) Item Number DYNJAP6120A, Pediatric Circuit 40in LF; 31) Item Number DYNJAP6124, Anesth Circ Pedi 60in 1L GSL; 32) Item Number DYNJAP6127, Anes Circ Pedi 60in-LF; 33) Item Number DYNJAP6130, Anesth Circ Ped 60in 1L-LF; 34) Item Number DYNJAP6132A, Circuit Pediatric Anesthesia; 35) Item Number DYNJAP6133, Anesth Circuit Peds 60in-LF; 36) Item Number DYNJAP6136, Circuit Peds Anesthesia; 37) Item Number DYNJAP6137, Circuit Pediatric Anesthesia; 38) Item Number DYNJAP7217A, Anesth Circuit 72in Exp Ped BI; 39) Item Number DYNJAP7225A, Circuit Pediatric Anesthesia; 40) Item Number DYNJAP7227, Anes. 90in Exp Pedi -LF; 41) Item Number DYNJAP7233, Anes. Circuit 90in Exp Pedi-LF; 42) Item Number DYNJAP7234A, Anesthesia 72in Pediatric Exp; 43) Item Number DYNJAP7235A, Anesth Circ 72in Ped; 44) Item Number DYNJAP7236A, Anesthesia Pedi 72in; 45) Item Number DYNJAP7237, Circuit Pedi 90in EXP; 46) Item Number DYNJAP7241A, Circuit Pediatric Anesthesia; 47) Item Number DYNJAP7243B, Circ Anesth Ped 2 B/V LFree; 48) Item Number DYNJAP7246C, Circuit Pediatric Anesthesia; 49) Item Number DYNJAP7247, Anes Circ Peds 90in Exp; 50) Item Number DYNJAP7248, Anesth Circ Ped 72in Exp; 51) Item Number DYNJAP7261, Circuit Pediatric Anesthesia; 52) Item Number DYNJAP7262, Circuit Pediatric Anesthesia; 53) Item Number DYNJAP7263, Pediatric Anesthesia Circuits; 54) Item Number DYNJAP9005, Anesthesia Circuit; 55) Item Number DYNJAP9721A, Anesth Circuit Pedi HMEF LF; 56) Item Number DYNJAP9725, Pedi Expand Circuit; 57) Item Number DYNJAP9726, Anesth Circ Ped 90in; 58) Item Number DYNJAP9729, Anesth Circ 90in Exp Ped; 59) Item Number DYNJAP9730A, Circuit Pediatric 60in CORR-LF; 60) Item Number DYNJAP9732A, Circuit Pediatric Anesthesia; 61) Item Number DYNJAP9735, Peds Circuit; 62) Item Number DYNJAP9739, Circuit Pediatric Anesthesia; 63) Item Number DYNJAP9740, Circuit Pediatric Anesthesia; 64) Item Number DYNJAP9743, Circuit Pediatric Anesthesia; 65) Item Number DYNJAPF6003, Anesth Circ 60in Ped Unilimb; 66) Item Number DYNJAPF6005A, Anesth Circ 60in Uni Peds; 67) Item Number DYNJAPF6006, Anes Circ Peds 60in Uni; 68) Item Number DYNJAPF6009, Peds Anesthesia Circuit-LF; 69) Item Number DYNJAPF6011, Circuit Pediatric Anesthesia; 70) Item Number DYNJAPF601
  • Manufacturer


  • Dirección del fabricante
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060-4486
  • Source