Recalls / —

—#144160

Product

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

FDA product code

GDO — Applier, Surgical, Clip

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

Model/Catalog: IRR-Clip-30 Lot # J023101962

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm

The Anspach Effort, Inc.

Address

4500 Riverside Dr, Palm Beach Gardens, Florida 33410-4235

Distribution

Distribution pattern

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

Timeline

Recall initiated

2015-11-02

Terminated

2016-05-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #144160. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.