Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Surgical Instruments
🏥 Medical Devices • 7,015 recalls
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489
W. L. Gore & Associates
Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or an inability to inflate.
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
NEO DELTA Self Safe, I.V. Catheter REF 3738222
Delta Med SpA
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
NEO DELTA SELFSAFE PUR T, I.V. Catheter:
Delta Med SpA
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent locking feature that will not allow the clinician to unlock the scalpel once the safety shield is closed and pushed forward into a locked position may result in a delay treatment/therapy, which could ultimately result in death.
NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
Delta Med SpA
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
Delta Med SpA
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
Epimed International
Potential for stylet to protrude from the distal end of the catheter
DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272
Delta Med SpA
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Angioplasty system has a manufacturing issue that has the potential to result in difficulty deflating the outer balloon, which may result in increased risk of access site complications.
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122
Delta Med SpA
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072
Delta Med SpA
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Mislabeled: Labeled on the package as 60mm contains 45mm devices