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U.S. Department of Health and Human Services

Class 2 Device Recall Surgical Skin Closure Device

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 Class 2 Device Recall Surgical Skin Closure Devicesee related information
Date Initiated by FirmFebruary 05, 2015
Date PostedMarch 02, 2015
Recall Status1 Terminated 3 on April 10, 2015
Recall NumberZ-1236-2015
Recall Event ID 70466
Product Classification Tape and bandage, adhesive - Product Code KGX
ProductZip 16 Surgical Skin Closure Device; 16 cm Product number PS1160; Rx only, Sterile Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
Code Information Lot 1002539, Exp 2015-06; 1002719, Exp.2015-08; 1002887, Exp 2015-10; 1003054, Exp 2015-12
Recalling Firm/
Manufacturer		 Zipline Medical
747 Camden Ave Ste A
Campbell CA 95008-4147
For Additional Information ContactMelissa Guerrero
408-684-0748
Manufacturer Reason
for Recall		The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.
FDA Determined
Cause 2		Packaging process control
ActionZipline sent an Urgent Voluntary product Recall letters to customers on February 5, 2015 by e-mail with possible follow up on site by firm representatives. The letter identified the affected product, problem and actions to be taken. Customers are asked to quarantine inventory immediately and examine the affected lots for complete pouch seals. Any product found with an incomplete seal should be destroyed or returned to ZipLine Medical. Please complete the enclosed response form as soon as possible, even if you no longer have stock of the lot numbers subject to this correction. This information is required to reconcile the inventory. Please contact Customer Service at 1-888-326-8999 to coordinate any product returns, replacement stock, or credit notes.
Quantity in Commerce3109 total, all model numbers
DistributionWorldwide Distribution - US Nationwide and the countries of Panama, Tehran, Ireland, Sweden, Japan, Hong Kong, Finland, Pakistan, Taiwan, Malaysia.
Total Product Life CycleTPLC 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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