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Lac-Mac
Lac-Mac Limited · Model 005DSBK-XL · UDI-DI 00627755551160
0
510(k) clearances
49
Adverse events
18
Recalls
560
Facilities
Description
Gown, non-surgical, Level 2, grippers at neck, tie at waist, special color coded neckband, Size XL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-31 | New York Embroidery Studio, Inc. | Gowns do not consistently meet the minimum liquid-barrier performance required. |
| 2024-06-03 | Stryker Corporation | Expired Products distributed to customers |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
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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.