| Date Initiated by Firm | November 02, 2015 |
|---|
| Create Date | March 24, 2016 |
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| Recall Status1 |
Terminated 3 on May 06, 2016 |
| Recall Number | Z-1246-2016 |
|---|
| Recall Event ID |
73197 |
| Product Classification |
Applier, surgical, clip - Product Code GDO
|
| Product | Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures. |
|---|
| Code Information |
Model/Catalog: IRR-Clip-30 Lot # J023101962 |
Recalling Firm/
Manufacturer |
The Anspach Effort, Inc.
4500 Riverside Dr
Palm Beach Gardens FL 33410-4235
|
| For Additional Information Contact | Jennifer Breston
561-627-1080 |
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Manufacturer Reason
for Recall | Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498). |
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FDA Determined
Cause 2 | Nonconforming Material/Component |
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| Action | On Nov 2, 2015 Anspach sent a letter to their customers informing them of the recall. Customer Immediate Actions: Please complete the attached reply form confirming your receipt of this letter. Return the completed form by fax to the number or email provided on the form. Returning the form promptly will prevent you from receiving repeat notices. If you distribute any of the products to other
services or facilities, please forward this information as appropriate. We understand this product recall removal) may have an impact on your facility. The FDA has recommended that healthcare facilities follow their risk management procedures as it relates to this notification. We apologize for any inconvenience that this Product Removal may create and appreciate your cooperation with our request. If you have any questions regarding this correction, please contact
the Complaint Handling Unit Manager at 561-494-3673 or contact your Anspach Sales Representative. |
|---|
| Quantity in Commerce | 50 clips |
|---|
| Distribution | Distributed in the states of PA and MN, and the country of Switzerland. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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