Z-1629-2014Class II

Anspach Irrigation Clip 40

Name: Z-1629-2014 Anspach Irrigation Clip 40
Creator: The Anspach Effort, Inc.
Published: 2013-12-03
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2013-12-03 / Terminated

FDA source

The Anspach Effort, Inc. began a recall of Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, shaping, and removal of... on 2013-12-03. FDA classified it as Class II and gives the reason as "The Irrigation Clips were assembled with the incorrect (smaller) clips". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1629-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-03
Posted: 2014-05-16
Terminated: 2016-04-18
Recalling firm: The Anspach Effort, Inc.
Product: Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, shaping, and removal of bone, including bones of the skull and spine.
Product code: FRN Pump, Infusion
Reason for recall: The Irrigation Clips were assembled with the incorrect (smaller) clips.
FDA root cause: Mixed-up of materials/components
Action: The firm, Anspach, sent an URGENT: Medical Device Removal letter dated December 3, 2013 to its customer. The letter described the product, problem and actions to be taken. Should you have any queries, please do not hesitate to contact Aspach Customer Support at (800) 327-6887.
Quantity in commerce: 150
Distribution: US Nationwide Distribution in the state of Mississippi.
Product codes and lots: Batch G323082757.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1629-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1629-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-16

Product code FRN

K030576Class IIAnspach Irrigation Pump and Irrigation Pump IIThe Anspach Effort, Inc. / cleared 2003-05-21

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)