Product Wiki · Recalls · U.S. FDA — Device Enforcement

AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC… — recall Z-0357-2017

U.S. FDA — Device Enforcement · Denmark · 2014-11-07 · Class II

As described by U.S. FDA — Device Enforcement: AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination with insulin infusion p

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0357-2017
Date of alert
2014-11-07
Country / jurisdiction
Denmark
Risk level
Class II
Risk type
recall
Brand
Unomedical As
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
Reported risk: Tubing detachment
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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