Zip 8M Wound Closure Device recall: Sterility Concern
Zip 8M Wound Closure Device; for wounds up to 8 cm in length; Product number PS9080; Rx only, Sterile Indicated for use during and after skin incision…
Why was Zip 8M Wound 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 1002750, Exp 2016-09
- Product
- Zip 8M Wound Closure Device; for wounds up to 8 cm in length; Product number PS9080; Rx only, Sterile Indicated for use during and after skin incision…
- Recalling firm
- Zipline Medical
- Quantity
- 3109 devices, 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)