Zip 16 Surgical Skin Closure Device recall: Sterility Concern
Zip 16 Surgical Skin Closure Device; 16 cm Product number PS1160; Rx only, Sterile Indicated for use during and after skin incision procedures to…
Why was Zip 16 Surgical Skin Closure Device recalled?
The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 1002539, Exp 2015-06; 1002719, Exp.2015-08; 1002887, Exp 2015-10; 1003054, Exp 2015-12
- Product
- Zip 16 Surgical Skin Closure Device; 16 cm Product number PS1160; Rx only, Sterile Indicated for use during and after skin incision procedures to…
- Recalling firm
- Zipline Medical
- Quantity
- 3109 total, all model numbers
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Panama, Tehran, Ireland, Sweden, Japan, Hong Kong, Finland, Pakistan, Taiwan, Malaysia.
- Recall date
- March 11, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)