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U.S. Department of Health and Human Services

Class 2 Device Recall T&A Pack

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  Class 2 Device Recall T&A Pack see related information
Date Initiated by Firm October 24, 2017
Create Date November 07, 2017
Recall Status1 Terminated 3 on July 02, 2018
Recall Number Z-0069-2018
Recall Event ID 78366
Product Classification General surgery tray - Product Code LRO
Product AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
Code Information Lot # 109138
Recalling Firm/
Manufacturer		 Windstone Medical Packaging, Inc.
1602 4th Ave N
Billings MT 59101-1521
For Additional Information Contact
406-259-6387
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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