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Prevantics® Device Swab Strip

PROFESSIONAL DISPOSABLES INTERNATIONAL, INC. · Model B123ST · UDI-DI 00310819001779

LKB

510(k) clearances

345

Adverse events (2 deaths)

Recalls

112

Facilities

Description

Pre-moistened swabs to disinfect needleless access sites prior to use. Strip of 8 swabs.

Recalls

Date	Firm	Reason
2024-02-23	MEDLINE INDUSTRIES, LP - Northfield	Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
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
2017-04-17	Madison Polymeric Engineering	Product is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae.
2014-08-05	Catheter Connections, Inc.	Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves due to potential improper packaging cap seal which may render the sealed cap non-s
2011-10-11	Alere San Diego	Alere has initiated a recall of the Professional Disposables International (PDI) alcohol prep products due to the potential presence of low levels of the microorganism Bacillus cer
2011-04-19	Vygon Corporation	Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial conta
2011-04-19	Vygon Corporation	Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial conta
2011-04-19	Vygon Corporation	Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial conta
2011-04-19	Vygon Corporation	Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial conta

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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.