Southmedic Inc.
Naperville, IL, US
SOUTHMEDIC, INC. appears in FDA device records in Naperville, IL. FDA records list 10 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Southmedic Inc. between 1984 and 2023. The busiest year on record is 1986, with 3. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1986 | 3 |
| 1993 | 1 |
| 1995 | 1 |
| 2002 | 1 |
| 2011 | 1 |
| 2014 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K222511 | Oxy2Pro | CCK | Substantially Equivalent | |
| K131410 | CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE), | CCK | Substantially Equivalent | |
| K101953 | SMDIA-1000 | CAF | Substantially Equivalent | |
| K014211 | OXYARM CO2 | CCK | Substantially Equivalent | |
| K945993 | VAPOFIL | CAD | Substantially Equivalent | |
| K923265 | FUNNEL ADAPTOR | CAD | Substantially Equivalent | |
| K863318 | AEROSOL-T | BZA | Substantially Equivalent | |
| K861839 | VAPOFIL | CAD | Substantially Equivalent | |
| K860545 | VAPORIZER SPACER | CAD | Substantially Equivalent | |
| K843993 | ANAESLOCK THREE VAPORIZER INTERLOCK HVA003 | CAD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8022032 | 3001717360 | SOUTHMEDIC, INC. | 50 ALLIANCE BLVD.,, BARRIE Ontario L4M 5K3 CA | 2026 | and 17 more, listed in full below |
| 3008567560 | 3008567560 | Southmedic Inc. | 2043 Corporate Lane, Naperville, IL 60563 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MNLAccessories, Cleaning Brushes, For Endoscope
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CACApparatus, Autotransfusion
- GESBlade, Scalpel
- GECBrush, Scrub, Operating-Room
- CATCannula, Nasal, Oxygen
- FLGCleaner, Ultrasonic, Medical Instrument
- BZAConnector, Airway (Extension)
- HHECup, Menstrual
- LIODevice, Specimen Collection
- OYJDna Specimen Collection, Saliva
- MNKEndoscopic Bite Block
- LROGeneral Surgery Tray
- GDZHandle, Scalpel
- MDMInstrument, Manual, Surgical, General Use
- CCWLaryngoscope, Rigid
- FHNLigator, Hemorrhoidal
- BYGMask, Oxygen
- CAFNebulizer (Direct Patient Interface)
- OTVResearch Use Only/Clinical Chemistry Devices
- OTTResearch Use Only/Microbiology
- GCZRetainer, Surgical
- KGSRetention Device, Suture
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- BSRStylet, Tracheal Tube
- CCXSupport, Patient Position
- MZRTopical Approximation System
- CADVaporizer, Anesthesia, Non-Heated
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0279-2023 | Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO | Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for sterilization, and was instead transferred directly to distribution where it was sold and distributed to customers as non-sterile product labelled as sterile. | Class II | Open, Classified | |
| Z-2141-2021 | OxyMask O2 Adult REF OM-1125-14 | Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of device function and use of the device could result in inappropriate or a lack of oxygen delivery to the patient. | Class II | Open, Classified | |
| Z-1892-2018 | Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue. | Scalpels lot contains non-sterile products labeled as sterile. | Class II | Terminated | |
| Z-1288-2018 | Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2. | Potential for loose or missing CO2 diffusers which could result in a non-functioning mask. | Class II | Terminated | |
| Z-0990-2011 | Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0615, Size #15, General Surgical Use, Sterile, unless package is damaged or opened., Southmedic Inc., 50 Alliance Blvd., Barrie, ON., Canada L4M 5K3 www.southmedic.com, Made in Canada. | Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile. | Terminated | ||
| Z-0989-2011 | Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0611, Size #11, General Surgical Use, Sterile, unless package is damaged or opened., Southmedic Inc., 50 Alliance Blvd., Barrie, ON., Canada L4M 5K3 www.southmedic.com, Made in Canada. | Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile. | Terminated | ||
| Z-0988-2011 | Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0610, Size #10, General Surgical Use, Sterile, unless package is damaged or opened., Southmedic Inc., 50 Alliance Blvd., Barrie, ON., Canada L4M 5K3 www.southmedic.com, Made in Canada. | Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile. | Terminated | ||
| Z-1190-06 | Vapofils with Stainless Steel Block Ends, Item Number V0507S (Sevofluane). The vapofil is a keyed anesthetic transfer tube that transfers the anesthetic from the bottle to the vaporizer. | Southmedic has initiated this recall because their Japanese distributor received field reports of leaking vapofils. Leakage may cause non-toxic spills in the hospital environment, distraction of practitioners during conduct of anesthesia and surgery, and may damage certain plastic equipment. Leakage may also expose patients to low concentrations of volatile anesthetics. | Terminated | ||
| Z-1189-06 | Vapofils with Stainless Steel Block Ends, Item Number V0507F (Isoflurane). The vapofil is a keyed anesthetic transfer tube that transfers the anesthetic from the bottle to the vaporizer. | Southmedic has initiated this recall because their Japanese distributor received field reports of leaking vapofils. Leakage may cause non-toxic spills in the hospital environment, distraction of practitioners during conduct of anesthesia and surgery, and may damage certain plastic equipment. Leakage may also expose patients to low concentrations of volatile anesthetics. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain