← InicioRecallRadarPR
🔴

PELIGROSO · Class I

Recall de Kits de conveniencia médica de Medline, que contienen jeringas de control de adaptador rotatorio angiográfico NAMIC (jeringas Namic RA), etiquetadas de la siguiente manera: 1. CATH LAB PACK-LF, SKU de Medline 00-HCT055P; 2. INTERVENTIONAL CATH LAB PK-LF, SKU de Medline DYNJ0376230Q; 3. ANGIOGRAPHY CATH LAB, SKU de Medline DYNJ23532C; 4. ANGIO LEFT HEART PACK, SKU de Medline DYNJ40632C; 5. ANGIO DRAPE PACK, SKU de Medline DYNJ47952B; 6. ANGIOGRAPHIC PACK, SKU de Medline DYNJ57516; 7. CATH LAB PACK, SKU de Medline DYNJ58243B; 8. CATH LAB PACK, SKU de Medline DYNJ65185; 9. CSU CATH MANIFOLD KIT, SKU de Medline VASC1170A; 10. MANIFOLD KIT NO TRANSDUCER, SKU de Medline VASC1184A. 2026: Qué Hacer Si Lo Tienes

📅 2026-04-15🏢 Medline Industries, LP#Z-1716-2026

La FDA publicó un recall peligroso para Kits de conveniencia médica de Medline, que contienen jeringas de control de adaptador rotatorio angiográfico NAMIC (jeringas Namic RA), etiquetadas de la siguiente manera: 1. CATH LAB PACK-LF, SKU de Medline 00-HCT055P; 2. INTERVENTIONAL CATH LAB PK-LF, SKU de Medline DYNJ0376230Q; 3. ANGIOGRAPHY CATH LAB, SKU de Medline DYNJ23532C; 4. ANGIO LEFT HEART PACK, SKU de Medline DYNJ40632C; 5. ANGIO DRAPE PACK, SKU de Medline DYNJ47952B; 6. ANGIOGRAPHIC PACK, SKU de Medline DYNJ57516; 7. CATH LAB PACK, SKU de Medline DYNJ58243B; 8. CATH LAB PACK, SKU de Medline DYNJ65185; 9. CSU CATH MANIFOLD KIT, SKU de Medline VASC1170A; 10. MANIFOLD KIT NO TRANSDUCER, SKU de Medline VASC1184A., fabricado por Medline Industries, LP. Este recall afecta a todo Estados Unidos, incluyendo Puerto Rico.

¿Por qué se retiró?

Medline Industries, LP ha identificado a través de la vigilancia post-comercialización un riesgo potencial de que el adaptador de rotación de la jeringa se desenrosque durante su uso, lo que puede resultar en una conexión suelta y/o una desconexión completa entre la jeringa y el colector.

🔍 Lotes Afectados

Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 24BBI341; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23LBP066; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23KBS305; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23JBA062; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23HBR594; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23DBR051; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 24ABO014; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 23KBW878; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 23HBP761; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 23FBW006; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 23DBF403; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25KMD905; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25IMD215; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25GMI326; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25FMI653; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25EMH566; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25DMI277; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25AMI608; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24LMH838; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24LMB458; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24JME629; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24GME647; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24GMB984; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24GMB351; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24EMF938; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24DMH385; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24CMH336; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24CMF956; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24BMA898; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24AMA108; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23HMH132; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23GMH036; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23GME698; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23FMF802; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23EMJ218; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24JMD976; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24HMA010; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24GMG026; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24GMB098; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24FMF601; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24EMB438; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24BMA764; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23LME233; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23JMH698; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23IMD171; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23GMD850; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23FMF778; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23EMG560; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 25LMG779; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 25IMJ214; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 25HMF990; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 25EMI063; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 25DMB127; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 25BMF602; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24LMF104; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24KMD144; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24JMA170; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24HMH276; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24HMA390; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24FMD853; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24DMJ147; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24CMH759; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24BMA225; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 23LMB166; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 23KMH325; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 23IME127; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 23HME466; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 23FMJ772; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 23FMB456; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 23EMC182; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 23DMH934; Medline SKU DYNJ57516, UDI/DI each 10889942748426, UDI/DI case 40889942748427, Lot Number 25JMI272; Medline SKU DYNJ57516, UDI/DI each 10889942748426, UDI/DI case 40889942748427, Lot Number 25HMG164; Medline SKU DYNJ57516, UDI/DI each 10889942748426, UDI/DI case 40889942748427, Lot Number 25HMF202; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 25LBB437; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 25HBV263; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 25GBR191; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 25GBR194; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 25GBR437; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 25EBO829; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 25BBR177; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 24JBX749; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 24JBG123; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 24IBJ506; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 24FBT677; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 24FBH497; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 24DBL409; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 24BBT394; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 24ABR246; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 23LBK160; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 23KBJ685; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 23IBU014; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 23IBG647; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 23HBB827; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 23FBU409; Medline SKU DYNJ65185, UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number 24ABQ959; Medline SKU DYNJ65185, UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number 23KBF277; Medline SKU DYNJ65185, UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number 23IBR043; Medline SKU DYNJ65185, UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number 23HBI873; Medline SKU DYNJ65185, UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number 23GBA252; Medline SKU DYNJ65185, UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number 23EBM886; Medline SKU VASC1170A, UDI/DI each 10193489774863, UDI/DI case 40193489774864, Lot Number 25HMD546; Medline SKU VASC1184A, UDI/DI each 10193489799828, UDI/DI case 40193489799829, Lot Number 25HBL365; Medline SKU VASC1184A, UDI/DI each 10193489799828, UDI/DI case 40193489799829, Lot Number 25GBL071; Medline SKU VASC1184A, UDI/DI each 10193489799828, UDI/DI case 40193489799829, Lot Number 24GBY914.

Busca estos números en el envase de tu producto. Si coinciden, sigue los pasos abajo.

🛡️ ¿Qué Hago Ahora?

  1. 1Verifica el número de lote en el envase del producto.
  2. 2Si lo tienes, no lo uses.
  3. 3Devuélvelo a tu farmacia o al lugar donde lo compraste para reembolso.
  4. 4Si ya lo usaste y te sientes mal, ve a tu médico inmediatamente.
  5. 5Reporta efectos adversos a la FDA: 1-800-FDA-1088.

Detalles del Recall

Producto
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CATH LAB PACK-LF, Medline SKU 00-HCT055P; 2. INTERVENTIONAL CATH LAB PK-LF, Medline SKU DYNJ0376230Q; 3. ANGIOGRAPHY CATH LAB, Medline SKU DYNJ23532C; 4. ANGIO LEFT HEART PACK, Medline SKU DYNJ40632C; 5. ANGIO DRAPE PACK, Medline SKU DYNJ47952B; 6. ANGIOGRAPHIC PACK, Medline SKU DYNJ57516; 7. CATH LAB PACK, Medline SKU DYNJ58243B; 8. CATH LAB PACK, Medline SKU DYNJ65185; 9. CSU CATH MANIFOLD KIT, Medline SKU VASC1170A; 10. MANIFOLD KIT NO TRANSDUCER, Medline SKU VASC1184A.
Empresa
Medline Industries, LP
Clasificación
Class I
Estatus
Ongoing
Cantidad
17902 kits
Distribución
Worldwide distribution: US (nationwide) including Puerto Rico (PR) and OUS (foreign) to countries of: Canada (CA), Netherlands (NL), Australia (AU), Korea, Republic of (KR), Sri Lanka (LK), Pakistan (PK), Japan (JP), United Arab Emirates (AE), Singapore (SG) and Slovakia (SK).

Esto NO es consejo médico. Consulta con tu farmacéutico o médico antes de tomar decisiones.