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IV Catheter Dressings
Dynarex Corporation · Model 4609 · UDI-DI 00616784460918
10
510(k) clearances
749
Adverse events (3 deaths)
7
Recalls
201
Facilities
Description
2.9" x 3.8" (7.4cm x 9.7cm)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-04-25 | Bard Access Systems Inc. | StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip. |
| 2016-12-09 | Bard Access Systems | Bard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices because some single unit pouches have been released without unique product id |
| 2016-12-09 | Bard Access Systems | Bard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices because some single unit pouches have been released without unique product id |
| 2013-06-10 | Bard Access Systems | BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly used during manufacture. The absence of the hydrocol |
| 2007-02-15 | Merit Medical Systems, Inc | Sterility of some units may be compromised due to damaged packaging. |
| 2007-02-15 | Merit Medical Systems, Inc | Sterility of some units may be compromised due to damaged packaging. |
| 2007-02-15 | Merit Medical Systems, Inc | Sterility of some units may be compromised due to damaged packaging. |
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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.