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

Recall Z-0987-2014 — SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

U.S. FDA — Device Enforcement · United States · 2014-01-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0987-2014
Date of alert: 2014-01-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: B. Braun Medical, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 0061339694

Reported risk: Complaints were received reporting leakage on certain lots of SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites.The SAFSITE¿ Injection Site is intended to provide needle free access on IV and Extension Sets.

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.

Recall Z-0987-2014 — SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

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