Zipline Medical Recalls Zip 8M Wound Closure Devices Due to Sterility Concerns
Zipline Medical is recalling Zip 8M Wound 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 sterile medical device where the lack of a seal compromises sterility assurance, creating a risk of infection. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zipline Medical is recalling the Zip 8M Wound Closure Device, product number PS9080. This sterile, prescription-only device 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 devices across all model numbers.
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 devices. The affected lot is 1002750, with an expiration date of September 2016.
The devices were distributed worldwide, including nationwide in the United States and in 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 instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- Zipline Medical
- Category
- Medical Device — Wound Closure
- 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 1002750
- Exp 2016-09
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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