The Recall Desk
HighFDA (Devices)·Z-0241-2017·Announced 2016-10-26

Windstone Medical Recalls Minor Ortho Packs Due to Sterility Concerns

Windstone Medical Packaging is recalling Minor Ortho Packs because disposable gloves in the kits 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 risk-of-harm product (compromised sterility in surgical kits) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 352 units of the Minor Ortho Pack, specifically kit numbers 002646-12 and 002646-13. These are convenience custom kits used for general surgery in hospital operating rooms. The recall was initiated because the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, included in the custom AMS kit may contain splits or holes that compromise sterility.

The affected kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The recall covers specific lot numbers and expiration dates ranging from August 2013 to June 2016.

Hospitals and surgical facilities should stop using these kits and contact the manufacturer for instructions on return or disposal. Patients who have had surgery using these specific kits should consult their healthcare provider if they have concerns about sterility or potential infection.

The recalled product

Product
Minor Ortho Pack, Kit number 002646-12 and 002646-13 convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
352

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.

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Same hazard · sterility compromise

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