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Recall Observatory FDA recall evidence

Device 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 procedures to approximate skin and hold together skin edges until healing can take place.

Z-1235-2015

February 05, 2015

Class II

Product summary

Firm
Zipline Medical
Event
Event 70466
Status
Terminated
Classification
Class II
Quantity
3109 devices, total all model numbers
Official record key
device-enforcement:Z-1235-2015

Official wording

Reason: The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.

Code information: Lot 1002750, Exp 2016-09

Distribution pattern: Worldwide Distribution - US Nationwide and the countries of Panama, Tehran, Ireland, Sweden, Japan, Hong Kong, Finland, Pakistan, Taiwan, Malaysia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.