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

Transpac¿ IV Monitoring Kit w/ Safeset" Reservoir and Blood Sampling Port, 03 ml Squeeze Flush Device, Macrodrip (Patient Mount), Item No. 46114-24 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure mon — recall Z-0568-2017

U.S. FDA — Device Enforcement · United States · 2016-09-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0568-2017
Date of alert: 2016-09-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: ICU Medical, Inc.
Product category: device
Product type: Devices

Reported risk: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

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.

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.

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