Windstone Medical Packaging, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0069-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.

Product Classification:

Class II

Date Initiated: October 24, 2017

Date Posted: November 15, 2017

Recall Number: Z-0069-2018

Event ID: 78366

Reason for Recall:

Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were subsequently recalled by CR Bard for a potential sterile barrier breach.

Status: Terminated

Product Quantity: 60 kits

Code Information:

Lot # 109138

Distribution Pattern:

US Distribution to the state of : SC

Voluntary or Mandated:

Voluntary: Firm initiated