Zipline Medical Recalls Zip 8i Surgical Skin Closure Devices
Zipline Medical is recalling Zip 8i Surgical Skin Closure Devices because the manufacturer's seal may be missing, compromising sterility assurance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterility failure in a surgical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Zipline Medical is recalling the Zip 8i Surgical Skin Closure Device, product number PS2080, which is indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place. The recall involves 3,109 units of all model numbers.
The recall is being issued because the manufacturer's seal may not be present on the Nylon pouch, resulting in a lack of assurance for sterility. The affected products are identified by Lot 1002690 with an expiration date of 2015-08.
The devices were distributed worldwide, including in the United States, Panama, Tehran, Ireland, Sweden, Japan, Hong Kong, Finland, Pakistan, Taiwan, and Malaysia. Users should stop using the affected devices and contact Zipline Medical for further instructions.
The recalled product
- Product
- Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number PS2080 Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
- Manufacturer
- Zipline Medical
- Hazard
- Affected units
- 3,109
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 1002690
- Exp 2015-08
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Zipline Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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See all →- HighZipline Medical Recalls Zip 8M Wound Closure Devices Due to Sterility Concerns
FDA (Devices) · 2015-03-11
- HighZipline Medical Recalls Zip 16 Surgical Skin Closure Devices
FDA (Devices) · 2015-03-11
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