Class I - Dangerous
Probe programming error. The incorrect program can generate more heat at the surgical site, resulting in an elevated probability of tissue damage.
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Surgical Instruments
🏥 Medical Devices • 7,015 recalls
Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
Resource Optimization & Innovation
Class I - Dangerous
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.
Resource Optimization & Innovation
Class I - Dangerous
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for cardiovascular surgery.
Resource Optimization & Innovation
Class I - Dangerous
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular surgery.
Resource Optimization & Innovation
Class I - Dangerous
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for cardiovascular surgery.
Resource Optimization & Innovation
Class I - Dangerous
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical kit for surgery.
Resource Optimization & Innovation
Class I - Dangerous
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical kit for surgery.
Resource Optimization & Innovation
Class I - Dangerous
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
Resource Optimization & Innovation
Class I - Dangerous
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Class I - Dangerous
Some 1 1/4" needles were packaged and labeled in the 1" blister package.
ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT
Baxter Healthcare
Class I - Dangerous
Potential for a leak at the tubing to luer bond.
Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.
Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
Biomet Microfixation
Class I - Dangerous
The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
Biomet Microfixation
Class I - Dangerous
The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
One Distal Access Catheter intended for distribution in Korea, was found at a US location.
4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
Arrow International
Class I - Dangerous
Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card with these products state the PICC can withstand up to ten (10) pressure injections, however, the PICC has only been tested to withstand five (5) pressure injections.
regard Item Number: 800524001, Sterile, LD0608A - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Resource Optimization & Innovation
Class I - Dangerous
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Resource Optimization & Innovation
Class I - Dangerous
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
regard Item Number: 800408001, Sterile, LD0477A - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Resource Optimization & Innovation
Class I - Dangerous
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - surgical kit containing cover light handle soft, Rx. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Resource Optimization & Innovation
Class I - Dangerous
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.