CLASS II Device recall · Reported 8 Jun 2016 · FDA Enforcement Report

General Surgery Pack recalled by Windstone Medical Packaging

Windstone Medical Packaging is recalling General Surgery Pack, distributed nationwide in the US. The recall was initiated on 21 Mar 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codeslot 56402, 57255, 60542, and 61506

Quantity recalled170 units

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-1870-2016
FDA event ID: 73743
Recalling firm: Windstone Medical Packaging, Billings, MT
Classification: Class II
Status: Terminated
Recall initiated: 21 Mar 2016
FDA classified: 1 Jun 2016
Reported: 8 Jun 2016
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Surgical Instruments

Timeline

21 Mar 2016	Recall initiated by company
1 Jun 2016	Classified by FDA	+72 days
8 Jun 2016	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

These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.

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

General Surgery Pack, part number 006880-3. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges.

Where it was distributed

Nationwide distribution to Louisiana and Montana.

Nationwide Louisiana Montana

Questions about this recall

Is General Surgery Pack recalled?

Yes. Windstone Medical Packaging recalled General Surgery Pack on 21 Mar 2016. The recall is Class II and its status is Terminated. Recall number Z-1870-2016.

Why was it recalled?

These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.

Which lots are affected?

lot 56402, 57255, 60542, and 61506

Where was it sold?

Nationwide distribution to Louisiana and Montana.

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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