Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
All Recalls
95,102 total recalls in our database
MEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in medical procedures.
MEDLINE INDUSTRIES, LP - Northfield
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in surgical procedures.
MEDLINE INDUSTRIES, LP - Northfield
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
CritiCool, thermoregulation device
Belmont Instrument
Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment and a failure to deliver the prescribed thermoregulation therapy. To date, the firm has received one report of death potentially related to this issue.
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P00697905
Baxter Healthcare
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).
BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical procedures.
MEDLINE INDUSTRIES, LP - Northfield
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
Boston Scientific
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.
MICROVENTION
Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher from being fully inserted into the controller, which may result in the inability of the controller to properly detach the implant device, which could cause delays and excessive manipulation that may cause the implant to move and damage vessels
MEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical procedures.
MEDLINE INDUSTRIES, LP - Northfield
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
BAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical procedures.
MEDLINE INDUSTRIES, LP - Northfield
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
BAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical procedures.
MEDLINE INDUSTRIES, LP - Northfield
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes in blood. BD Trucount Tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount Tubes can be used with the BD FACS Loader.
Becton, Dickinson and Company, BD Biosciences
Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant. Firm root cause investigation confirmed that label detachment is due to an adhesive change by a tier 2 supplier.
BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures.
MEDLINE INDUSTRIES, LP - Northfield
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min (3660 mL/hr)
Becton Dickinson Infusion Therapy Systems
During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed).
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).
Unable to charge the battery pack- battery packs will allow the batteries to be charged if the voltage of any cell is below 2.5V. When this occurs, the battery pack will not accept the charge, could vent and possibly catch fire
MEDLINE LINQ TRAY, REF DYNJ65880A. Convenience kit used in medical/surgical procedures.
MEDLINE INDUSTRIES, LP - Northfield
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair
BAUSCH + LOMB CATARACT PACK, REF VAL009CTSGA. Convenience kit used in surgical procedures.
MEDLINE INDUSTRIES, LP - Northfield
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.