Windstone Medical Packaging, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1868-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Laparotomy Pack, Part numbers 006268-8 and 007725-8. 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, Tray Pack, 8" x 32" W/L.

Product Classification:

Class II

Date Initiated: March 21, 2016

Date Posted: June 8, 2016

Recall Number: Z-1868-2016

Event ID: 73743

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.

Status: Terminated

Product Quantity: 386 units

Code Information:

Lot: 55950, 56349, 57461, 58034, 58492, 70671, 70930, 71324, 71726, 71892, 72656, 73071, 74331, 75004, and 75545.

Distribution Pattern:

Nationwide distribution to Louisiana and Montana.

Voluntary or Mandated:

Voluntary: Firm initiated