VERSAPOINT, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). US Distribution/Manufactured for
FDA device recall Z-0493-05 · posted 2005-02-02 · Terminated
Recall details
- Recalling firm
- Ethicon, Inc
- Reason for recall
- Deformation of the Verspoint Hysteroscopic System Connector Cable hand grips when autoclaved causing possible non-sterile electrodes.
- Action taken
- The recall letter was mailed to the Director of Material Management and the Director of Operating Room on December 14, 2004.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HIH
- Quantity affected
- 891electrodes
- Distribution
- Ethicon distributed the devices to 166 hospitals in the US. There are no Government sales. Product sold to other countries was distributed directly from the manufacturerin England to Ethicon distribut
- Date initiated
- 2004-12-16
- Date posted
- 2005-02-02
- Date terminated
- 2005-10-31
- Location
- Somerville, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
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| SCUBA SYSTEM (K962482) | Gynecare, Inc. | 1996-11-01 |