Z-1246-2016Class II

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

Name: Z-1246-2016 Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures
Creator: The Anspach Effort, Inc.
Published: 2015-11-02
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2015-11-02 / Terminated / root cause: manufacturing process

FDA source

The Anspach Effort, Inc. began a recall of Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures on 2015-11-02. FDA classified it as Class II and gives the reason as "Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1246-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-02
Posted: 2016-03-24
Terminated: 2016-05-06
Recalling firm: The Anspach Effort, Inc.
Product: Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures.
Product code: GDO Applier, Surgical, Clip
Reason for recall: Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498).
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Product codes and lots: Model/Catalog: IRR-Clip-30 Lot # J023101962

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1246-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1246-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-24

Product code GDO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)