Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter
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Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138; 4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142; 5) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142B; 6) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145; 7) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145B; 8) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5; 9) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5B; 10) NEURO PACK-LF, Model Number: DYNJ0305809O; 11) NEURO PACK-LF, Model Number: DYNJ0305809P; 12) NEURO PACK-LF, Model Number: DYNJ0408776Y; 13) NEURO PACK-LF, Model Number: DYNJ04596K; 14) NEURO/LAMINECTOMY BASIN PK-LF, Model Number: DYNJ0781823K; 15) BASIC NEURO PACK SMMC-LF, Model Number: DYNJ35243L; 16) NEURO PACK, Model Number: DYNJ49098I; 17) NEURO PACK, Model Number: DYNJ53089B; 18) NEURO LAMINECTOMY-LF, Model Number: DYNJ53799; 19) NEURO MINOR PACK-UNIV, Model Number: DYNJ58704A; 20) NEURO PACK - IFCAP 230316, Model Number: DYNJ60100C; 21) NEURO PACK, Model Number: DYNJ60792B; 22) NEURO PACK, Model Number: DYNJ60792C; 23) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157C; 24) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157D; 25) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157F; 26) CHRISTUS CHILDRENS NEURO PK, Model Number: DYNJ61168D; 27) NEURO PACK, Model Number: DYNJ61740D; 28) NEURO ST DAVIDS MEDICAL CTR, Model Number: DYNJ61998; 29) NEURO GOODIE PACK - DUNN, Model Number: DYNJ64570A; 30) DISCECTOMY PACK, Model Number: DYNJ67835; 31) FSC NEURO PACK, Model Number: DYNJ80442B; 32) WWD NEURO PACK, Model Number: DYNJ80849B; 33) WWD NEURO PACK, Model Number: DYNJ80849C; 34) WWD NEURO PACK, Model Number: DYNJ80849D; 35) WWD NEURO PACK, Model Number: DYNJ80849F; 36) WWD NEURO PACK, Model Number: DYNJ80849G; 37) WWD NEURO PACK, Model Number: DYNJ80849I; 38) WWD NEURO PACK, Model Number: DYNJ80849J; 39) NEURO DIAGNOSTIC, Model Number: DYNJ84653A; 40) NEURO, Model Number: DYNJ900904J; 41) NEURO, Model Number: DYNJ900904K; 42) NEURO, Model Number: DYNJ900904L; 43) NEURO, Model Number: DYNJ900904M; 44) NEURO, Model Number: DYNJ902585; 45) NEURO, Model Number: DYNJ902585A; 46) NEURO - IFCAP 230316, Model Number: DYNJ908393; 47) NEURO - IFCAP 230316, Model Number: DYNJ908393A; 48) NEURO - IFCAP 230316, Model Number: DYNJ908393B; 49) NEURO KIT, Model Number: DYNJ909573; 50) NEURO, Model Number: DYNJ910384; 51) NEURO, Model Number: DYNJ910384A; 52) NEURO PACK-LF, Model Number: PHS390015M. Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.. Classification: Class II. Quantity: 10184 units. Distribution: Worldwide - US Nationwide distribution.
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During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.