The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1236-2015·Announced 2015-03-11

Zipline Medical Recalls Zip 16 Surgical Skin Closure Devices

Zipline Medical is recalling Zip 16 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 (sterile medical device) where the lack of sterility assurance poses a potential risk of infection, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Zipline Medical is recalling the Zip 16 Surgical Skin Closure Device, product number PS1160. The recall involves 3,109 units across all model numbers. These devices are indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.

The recall was initiated because the manufacturer's seal may not be present on the Nylon pouch. This defect results in a lack of assurance for the sterility of the device. The affected lots are 1002539 (Exp 2015-06), 1002719 (Exp 2015-08), 1002887 (Exp 2015-10), and 1003054 (Exp 2015-12).

The devices were distributed worldwide, including the United States, Panama, Tehran, Ireland, Sweden, Japan, Hong Kong, Finland, Pakistan, Taiwan, and Malaysia. Healthcare providers and facilities should stop using these devices and contact Zipline Medical for further instructions.

The recalled product

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 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 (8)

  • Lot 1002539
  • Exp 2015-06
  • 1002719
  • Exp.2015-08
  • 1002887
  • Exp 2015-10
  • 1003054
  • Exp 2015-12

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

Same manufacturer · Zipline Medical

See all →

Same hazard · sterility compromise

See all →

Similar recalls