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BaaySCI Alcohol Disinfecting Prep Pads
HOME AIDE DIAGNOSTICS, INC. · Model ALC100 · UDI-DI 00891237001959
10
510(k) clearances
345
Adverse events (2 deaths)
9
Recalls
112
Facilities
Description
• 2-ply pads • Saturated with 70% isopropyl alcohol • 100 individually packed alcohol pads per box • For external use only
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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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.