The Recall Desk
HighFDA (Devices)·Z-0213-2017·Announced 2016-10-26

Windstone Medical Recalls Knee Scope Packs Due to Sterility Concerns

Windstone Medical Packaging is recalling 272 Knee Scope Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a defect (glove splits/holes) compromises sterility, creating a risk of harm (infection) to patients, but the source text does not report any specific illnesses or injuries.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 272 units of the Knee Scope Pack, Kit number AMS2498 and AMS2498(A. These are convenience custom kits used for general surgery in hospital operating rooms. The recall is due to a defect in the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, which are included in the custom AMS kit.

The FDA determined that the gloves may contain splits or holes that compromise sterility. This defect poses a risk of infection to patients during surgical procedures. The affected kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

Healthcare facilities should stop using the affected Knee Scope Packs immediately. The specific lot numbers and expiration dates for the recalled units are 62085 (11/12/2015), 64546 (1/4/2016), 67402 (7/13/2016), 67696 (8/21/2016), 68498 (9/18/2016), 70496 (9/23/2016), 74549 (5/9/2017), 76677 (7/19/2017), 75582 (7/22/2017), and 77685 (no expiration date provided).

The recalled product

Product
Knee Scope Pack, Kit number AMS2498 and AMS2498(A convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
272

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 150 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 150 products in this recall →

Related recalls

Same manufacturer · Windstone Medical Packaging, Inc.

See all →

Same hazard · sterility compromise

See all →