Southwest Technologies Inc
North Kansas City, MO, US
SOUTHWEST TECHNOLOGIES, INC. appears in FDA device records in North Kansas City, MO. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 6 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 5 510(k) clearances for Southwest Technologies Inc between 1987 and 2010. The busiest year on record is 1987, with 2. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 2 |
| 2004 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K102478 | OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING | FRO | Substantially Equivalent | |
| K083334 | ELASTO-GEL MANUKA HONEY WOUND DRESSING | FRO | Substantially Equivalent | |
| K030774 | STIMULEN COLLAGEN | KGN | Substantially Equivalent | |
| K872488 | ELASTO-GEL CAST & SPLINT PADS | IPM | Substantially Equivalent for Some Indications | |
| K872165 | ELASTO-GEL OCCLUSIVE DRESSING | FRO | Substantially Equivalent for Some Indications |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1929833 | 1929833 | SOUTHWEST TECHNOLOGIES, INC. | 1746 LEVEE RD., North Kansas City, MO 64116 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2109-2021 | Stimulen Collagen Moisturizing Lotion, ST9555B | Dose audit failure after sterilization process | Class II | Open, Classified | |
| Z-0687-2020 | Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic | Elasto-Gel Wound Dressing may be contaminated with mold. | Class II | Terminated | |
| Z-1602-2018 | HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), SL3000 (b) Elasto-Gel(TM), SL3000LV (c) Elasto-Gel(TM), SL3001 (d) Elasto-Gel(TM), SL3007 (e) Elasto-Gel(TM), SL3008 | Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during chemotherapy treatments. Additionally, Southwest Technologies, Inc. was informed of 2 events of frostbite to digits in the last year while using the hypothermia mitts. | Class II | Open, Classified | |
| Z-1601-2018 | HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), TM7006 (b) Elasto-Gel(TM), TM7006LV (c) Elasto-Gel(TM), TM7007 (d) Elasto-Gel(TM), TM7008 (e) Elasto-Gel(TM), TM7008b (f) Elasto-Gel(TM), TM7009 (g) Elasto-Gel(TM), TM7010 (h) Elasto-Gel(TM), TM7011 (i) Elasto-Gel(TM), TM7012 | Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during chemotherapy treatments. Additionally, Southwest Technologies, Inc. was informed of 2 events of frostbite to digits in the last year while using the hypothermia mitts. | Class II | Open, Classified | |
| Z-1600-2018 | HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), CAP610 (b) Elasto-Gel(TM), CAP610LV (c) Elasto-Gel(TM), CAP613 (d) Elasto-Gel(TM), CAP617 (e) Elasto-Gel(TM), CAP619 (f) Elasto-Gel(TM), CAP619LV (g) Elasto-Gel(TM), CAP622 | Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during chemotherapy treatments. Additionally, Southwest Technologies, Inc. was informed of 2 events of frostbite to digits in the last year while using the hypothermia mitts. | Class II | Open, Classified | |
| Z-0841-06 | Elasto-Gel Wound Dressings, 3 product codes: DR8050, DR 8000, and DR 8000LV (for foreign distribution only), 4'' x 4'', Sterile, each package contains 1 wound dressing, 5 packages per intermediate box, 20 intermediate boxes (100 pkgs) per case. The label shows the product is Manufactured by Southwest Technologies, Inc., North Kansas City, MO. | The product is labeled as sterile and one of the lots failed sterility during the quarterly radiation dose audit. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Southwest Technologies Inc edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain