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

Recall Z-0991-2014 — MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: BioCardia Inc. San Carlos, CA 94070 Intended to provide a pathway through which medical instruments such as balloon dilation catheters, guidew

U.S. FDA — Device Enforcement · United States · 2014-02-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0991-2014
Date of alert: 2014-02-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Biocardia, Inc.
Product category: device
Product type: Devices

Reported risk: Tyvek packaging may be worn, causing loss of package integrity.

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.

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