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

Recall Z-0990-2014 — Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing; Single-Use Set Orbit Infusion Sets are sterile, non-pyrogenic, single-use devices intended to be used for subcutaneous delivery of medication , for example insulin, from an external infusion pump.

U.S. FDA — Device Enforcement · United States · 2013-12-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0990-2014
Date of alert
2013-12-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Perrigo Diabetes Care
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
7613117009502
Reported risk: Perrigo was notified by our supplier, Ypsomed AG, that they are recalling these batches due to being manufactured with a non-conforming female luer-lock connector. The luer-lock connectors are incompatible with standard male luer-lock connectors for use in connection to compatible infusion pumps. Perrigo became was notified of a quality complaint related to this issue on November 20, 2013 from a
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.