Z-0069-2018Class II

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

Name: Z-0069-2018 AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO
Creator: Windstone Medical Packaging, Inc.
Published: 2017-10-24
License: https://open.fda.gov/license/

Windstone Medical Packaging, Inc. / initiated 2017-10-24 / Terminated / root cause: manufacturing process

FDA source

Windstone Medical Packaging, Inc. began a recall of AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO on 2017-10-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0069-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-24
Posted: 2017-11-07
Terminated: 2018-07-02
Recalling firm: Windstone Medical Packaging, Inc.
Product: AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
Product code: LRO General Surgery Tray
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm (AMS) initiated the recall by email on October 24, 2017. The firm requested that the consignee identify and quarantine the product. Respond to AMS with a count and AMS will provide labeling (stickers) for the consignee to affix to the exterior of the kit. The sticker identifies the affected component and requests removal and destruction. For further questions, please call (406) 259-6387.
Quantity in commerce: 60 kits
Distribution: US Distribution to the state of : SC
Product codes and lots: Lot # 109138

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0069-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0069-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-15	2017-11-07

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)