CLASS II Device recall · Reported 2 Jul 2014 · FDA Enforcement Report

AnspachREF 98-0037Custom Device SC2102 with fast stop recalled

The Anspach Effort is recalling Anspach***REF 98-0037***Custom Device SC2102 with fast stop, distributed nationwide in the US. The recall was initiated on 28 Nov 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number: 98-0037; Serial Number: 2000940.

Quantity recalled1

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-1896-2014
FDA event ID: 64247
Recalling firm: The Anspach Effort, Palm Beach Gardens, FL
Classification: Class II
Status: Terminated
Recall initiated: 28 Nov 2012
FDA classified: 25 Jun 2014
Reported: 2 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Medical Software

Timeline

28 Nov 2012	Recall initiated by company
25 Jun 2014	Classified by FDA	+574 days
2 Jul 2014	Published in enforcement report	+7 days

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

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Product as listed by the FDA

ANSPACH***REF 98-0037***Custom Device SC2102 with fast stop firmware***Rx Only*** This device is intended to be used with Anspach Systems

Where it was distributed

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

Nationwide Alabama California Florida Iowa Illinois Kentucky Minnesota Mississippi North Carolina Ohio Oklahoma Pennsylvania Tennessee Texas

Questions about this recall

Is Anspach***REF 98-0037***Custom Device SC2102 with fast stop recalled?

Yes. The Anspach Effort recalled Anspach***REF 98-0037***Custom Device SC2102 with fast stop on 28 Nov 2012. The recall is Class II and its status is Terminated. Recall number Z-1896-2014.

Why was it recalled?

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Which lots are affected?

Part Number: 98-0037; Serial Number: 2000940.

Where was it sold?

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

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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