Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Medline convenience kits: INPATIENT CENTRAL LN DRSG KIT DYNDC3525 PICC/CV...
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI MID...
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI...
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47269D PORT-A-...
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Medline convenience kits: DISCECTOMY PACK DYNJ86476B EAR DYNJ81460C DYN...
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Description/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI CVC ...
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Medline convenience kits: ACL PACK DYNJ64161C ARTHROSCOPY PACK DYNJ47103...
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
Medline convenience kits: C-SECTION KIT DYNJ904305J C-SECTION PACK DYNJ6...
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Description/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Medline convenience kits: BREAST-HERNIA-PORT CDS-LF CDS984853L
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Medline convenience kit: HERNIA REPAIR TOTE DYNJ908337D
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)...
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Cat...
Potential for overpressure alerts.
Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5...
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Number...
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Medline convenience kit: SMSC-PELVISCOPY PACK-LF DYNJ0161619M
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
HarmonyAIR A-Series Surgical Lighting System
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Medline convenience kits: FEMORAL BLOCK TRAY DYNJRA1739B
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
BLOCK TRAY DYNJRA2119A INDWELLING NERVE BLOCK DYNJRA1011A
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Medline convenience kits: ACD DYNJ904999J ACDF DYNJ907336B DYNJ910821A ...
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A ...
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Pr...
Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.