Home › Device types › KXG
Applicator, Absorbent Tipped, Sterile
FDA product code KXG · Class 1 · General Hospital
947
Registered devices
834
Adverse events
10
Recalls
1
510(k) clearances
Devices with this code
Puritan — Puritan Medical ProductsHanHeng — Jiangsu HanHeng Medical Technology Co., LtdPuritan — Puritan Medical ProductsCLASSIQSwabs™ — COPAN ITALIA SPAHanHeng — Jiangsu HanHeng Medical Technology Co., LtdPuritan HydraFlock — Puritan Medical ProductsRENONMED — Zhejiang Renon Medical Instrument Co., Ltd.STRADIS — STRADIS MEDICAL, LLCNATIONAL HOSPITAL PACKAGING — Surgi-Pak, Inc.HanHeng — Jiangsu HanHeng Medical Technology Co., LtdPuritan PurFlock Ultra — Puritan Medical ProductsCLASSIQSwab — COPAN ITALIA SPACustom Healthcare Systems Inc. — Manus Medical, LLCPuritan — Puritan Medical ProductsNATIONAL HOSPITAL PACKAGING — Surgi-Pak, Inc.Specimen Collection Swab — TYPENEX MEDICAL LLCFLOQBrush™ — COPAN ITALIA SPACenturion — CENTURION MEDICAL PRODUCTS CORPORATIONiClean — Huachenyang (Shenzhen) Technology Co., LtdPuritan HydraFlock — Puritan Medical ProductsPuritan HydraFlock — Puritan Medical ProductsPuritan — Puritan Medical ProductsHanHeng — Jiangsu HanHeng Medical Technology Co., LtdDukal — Dukal LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-02-21 | Puritan Medical Products Company, Llc | It was discovered through a customer complaint that mislabeled product was distributed. Puritan distributed product labelled as 25-3317-H lot S1014 which contai |
| 2023-04-25 | LumiraDx | Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. If the swab breaks in the nasal cavity of a patient ma |
| 2022-11-02 | Stradis Medical, LLC dba Stradis Healthcare | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may r |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2021-07-09 | Copan Italia | A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano. |
| 2020-09-16 | Merit Medical Systems, Inc. | The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyar |
| 2014-12-22 | Puritan Medical Products Co., LLC | Shaft breaks so that adequate patient specimen sample cannot be obtained. |
| 2014-02-05 | Fisher Scientific Co | A customer reported the presence of an organism in a lot of Calcium Alginate Fiber Tipped Wood Applicator Swab. |
| 2013-06-05 | Fisher Scientific Co | The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presence of non-pathogenic organisms in two lots. The finding was con |
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