Endopath Probe Plus II, Hand-Controlled PistolGrip Handle, Product Code EPH02.
FDA device recall Z-0917-06 · posted 2006-05-31 · Terminated
Recall details
- Recalling firm
- Ethicon Endo-Surgery Inc
- Reason for recall
- There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device.
- Action taken
- The recalling firm sent a recall letter by United Parcel Services to all consignees for delivery to each consignee on 4/24/06. The letter requested subaccount address return information to the recalling firm.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 186 cases/6 devices per case.
- Distribution
- The recalled product was distributed throughout the United States and to foreign consignees including Argentina, Australia, Austria, Bahrain, Brazil, Canada, China, Colombia, Czech Republic, Dominican
- Date initiated
- 2006-04-20
- Date posted
- 2006-05-31
- Date terminated
- 2012-09-26
- Location
- Cincinnati, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EVACUATION/IRRIGATION/ELECROSURGICAL DEVICE (K912492) | ETHICON, Inc. | 1991-10-21 |