CLASS II Device recall · Reported 30 Mar 2016 · FDA Enforcement Report

Irrigation Clip recalled by The Anspach Effort

The Anspach Effort is recalling Irrigation Clip 30, distributed in Minnesota, Pennsylvania. The recall was initiated on 2 Nov 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Catalog: IRR-Clip-30 Lot # J023101962
Quantity recalled50 clips

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1246-2016
FDA event ID
73197
Recalling firm
The Anspach Effort, Palm Beach Gardens, FL
Classification
Class II
Status
Terminated
Recall initiated
2 Nov 2015
FDA classified
24 Mar 2016
Reported
30 Mar 2016
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

2 Nov 2015Recall initiated by company
24 Mar 2016Classified by FDA+143 days
30 Mar 2016Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

MinnesotaPennsylvania

Questions about this recall

Is Irrigation Clip 30 recalled?

Yes. The Anspach Effort recalled Irrigation Clip 30 on 2 Nov 2015. The recall is Class II and its status is Terminated. Recall number Z-1246-2016.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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