CARDINAL HEALTH

Technical Specs

Storage Environment Temperature

15°C to 30°C

MRI safety

Labeling does not contain MRI Safety Information

Sterile

Yes

Single use

Yes

Prescription use

Rx only

FDA distribution status

In Commercial Distribution

Device type (GMDN)

Orthopaedic surgical procedure kit, medicated

FDA product classification

Orthopedic tray

Typical Location

Where this class of equipment is typically deployed - general reference, not this unit's own placement record.

• Varies by device - check the unit's own manual for facility placement guidance

Documents & Manuals

No documents available for this device yet.

Safety & Recalls

Synced live from the FDA openFDA API.

• RECALL

  Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.

• RECALL

  The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.

• RECALL

  The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.

• RECALL

  Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.

• RECALL

  Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

• RECALL

  Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.

• RECALL

  The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.

• RECALL

  The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.

• RECALL

  Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.

• RECALL

  Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity

• RECALL

  Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .

• RECALL

  Product was distributed without being sterilized.

• RECALL

  There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

• RECALL

  Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.

• RECALL

  The suction valve may not close properly which could cause continuous suction.

• RECALL

  Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.