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Specimen Collection Swab
HLB CO.,LTD · Model FASPS02 · UDI-DI 08809262391343
1
510(k) clearances
813
Adverse events (1 deaths)
10
Recalls
282
Facilities
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 contained product code 25- |
| 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 may cause injury or me |
| 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 result in a breach in |
| 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 lots received between 0 |
| 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 lots received between 0 |
| 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 nasophyaryngeal cavity or a d |
| 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 confirmed in lot 61513 |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.