FDA Recall Terminated

Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures.

Recall: Z-1246-2016 · Initiated November 2, 2015

Recall

Recall Number
Z-1246-2016
Event Number
73197
Firm
The Anspach Effort, Inc.
FEI Number
1045834
Product Code
GDO
Status
Terminated
Root Cause
Nonconforming Material/Component
Initiated
November 2, 2015
Terminated
May 6, 2016
Address
4500 Riverside Dr, Palm Beach Gardens, FL, 33410-4235

Description

Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures.

Reason

Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498).

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.

Distribution

Distributed in the states of PA and MN, and the country of Switzerland.

Quantity

50 clips