The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1234-2015·Announced 2015-03-11

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Category
Medical Device — Surgical Instruments
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 →

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