FDA Medical Device Recalls (openFDA)
Windstone Medical Packaging, Inc.: AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
- Recall number
- Z-0069-2018
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
- Status
- Terminated
- Initiated
- 2017-10-24
- Posted
- not on file
- Terminated
- 2018-07-02
- Reason
- 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
- 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
- 60 kits
- Distribution
- US Distribution to the state of : SC
- Lot, serial or model codes
- Lot # 109138
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1000125955
- Firm city
- Billings
- Firm state
- MT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28