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C.D.RICH

Chengdu Rich Science Industry Co., Ltd. · Model PA 10cm · UDI-DI 16935238804124

KXG

510(k) clearances

813

Adverse events (1 deaths)

Recalls

282

Facilities

Description

A swab consists of a swab stick and a swab tip. The swab stick is made from ABS. The swab tip is made from polyamide fiber (Nylon) .The product is applicable to the collection of human respiratory tract specimen and mouth mucosa specimen.

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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Data 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.