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Silicone Birth Vac Cup
FORTUNE MEDICAL INSTRUMENT CORP. · Model 1300-0060 · UDI-DI 04710961930006
1
510(k) clearances
751
Adverse events (111 deaths)
6
Recalls
16
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-09 | Clinical Innovations, LLC | Due to complaints of device breakage at the traction force gauge to handle joint. |
| 2019-08-06 | Clinical Innovations, LLC | There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system. |
| 2008-01-16 | Cooper Surgical, Inc. | Vacuum Assisted Delivery System may have a loss of vacuum, or the cup will not release from the baby's head. A loss of vacuum may delay delivery and require the use of forceps and/ |
| 2008-01-16 | Cooper Surgical, Inc. | Vacuum Assisted Delivery System may have a loss of vacuum, or the cup will not release from the baby's head. A loss of vacuum may delay delivery and require the use of forceps and/ |
| 2008-01-16 | Cooper Surgical, Inc. | Vacuum Assisted Delivery System may have a loss of vacuum, or the cup will not release from the baby's head. A loss of vacuum may delay delivery and require the use of forceps and/ |
| 2004-08-17 | CooperSurgical, Inc. | Product is mislabeled as a Mushroom Cap Vacuum but actually contains a Bell Style Assisted Delivery System |
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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.