Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures.
FDA Recall Z-1246-2016 · Posted None
Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeGDO
Date Initiated2015-11-02
Date Terminated2016-05-06
Product Quantity50 clips
Reason for Recall
Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498).
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distributed in the states of PA and MN, and the country of Switzerland.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.