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U.S. Department of Health and Human Services

Class 2 Device Recall Laparotomy Pack Latex Free

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  Class 2 Device Recall Laparotomy Pack Latex Free see related information
Date Initiated by Firm March 21, 2016
Create Date June 01, 2016
Recall Status1 Terminated 3 on August 16, 2016
Recall Number Z-1869-2016
Recall Event ID 73743
Product Classification Kit, i.V. Start - Product Code LRS
Product Laparotomy Pack Latex Free, part number 007725-7. This is a custom convenience surgical instrument disposable kit.

There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges.
Code Information lot 55689, 55263, and 57680
Recalling Firm/
Manufacturer		 Windstone Medical Packaging, Inc.
1602 4th Ave N
Billings MT 59101-1521
For Additional Information Contact Vicki Davis
321-527-7714
Manufacturer Reason
for Recall		 These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.
FDA Determined
Cause 2		 Packaging
Action Aligned Medical Solutions (AMS) sent the Urgent Medical Device Recall letter, dated March 21, 2016, and the Recall Reply Form to their consignees via email. AMS informed consignees that their AMS packs (surgical kits) contained Kerlix X-Ray Detectable Laparotomy Sponge which was recalled by Medtronic. Consignees were advised to follow the over-labeling instructions and dispose the Kerlix X-Ray Detectable Laparotomy Sponge at the time the surgical kit is opened for use. Consigneeswere instructed to follow the "Instruction for placing Recall Notice Label to Packs" and label any kits remaining inventory. Consignees should return the Reply Form via fax at 407-865-7456 or call 321-527-7714 for any questions about this recall.
Quantity in Commerce 40 units
Distribution Nationwide distribution to Louisiana and Montana.
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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