CLASS II Device recall · Reported 18 Nov 2015 · FDA Enforcement Report

DeRoyal Sterile Custom Sterile Custom Surgical Kits recalled

DeRoyal Industries is recalling DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical, distributed in 7 states. The recall was initiated on 31 Aug 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF 89-5720.04, Lot Number 38322988; REF 89-6717.03, Lot Numbers: 38323059 and 38342436

Quantity recalledN/A

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-0241-2016
FDA event ID: 72098
Recalling firm: DeRoyal Industries, Powell, TN
Classification: Class II
Status: Terminated
Recall initiated: 31 Aug 2015
FDA classified: 6 Nov 2015
Reported: 18 Nov 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Pacemakers & Defibrillators

Timeline

31 Aug 2015	Recall initiated by company
6 Nov 2015	Classified by FDA	+67 days
18 Nov 2015	Published in enforcement report	+12 days

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

Reason for recall

Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant during package sterilization.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE or 2016-09EF, or 2016-09EG, or Catalog No. 863, Lot No. 2016-08DC: TOTAL JOINT PACK A&B, REF 89-5720.04; PACEMAKER PACK, REF 89-6717.03

Where it was distributed

SC, FL, OH, NJ, OK, MN, AR

Arkansas Florida Minnesota New Jersey Ohio Oklahoma South Carolina

Questions about this recall

Is DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical recalled?

Yes. DeRoyal Industries recalled DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical on 31 Aug 2015. The recall is Class II and its status is Terminated. Recall number Z-0241-2016.

Why was it recalled?

Which lots are affected?

REF 89-5720.04, Lot Number 38322988; REF 89-6717.03, Lot Numbers: 38323059 and 38342436

Where was it sold?

SC, FL, OH, NJ, OK, MN, AR

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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