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

Recall Z-2277-2012 — 16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device is used for patients requiring hemodialysis. The HemoStar XK catheter is made of radio-opaque polyurethane and allows for flow rates as high as 500 ml/min during hemodialysis t

U.S. FDA — Device Enforcement · United States · 2012-08-07 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2277-2012
Date of alert: 2012-08-07
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Bard Access Systems
Product category: device
Product type: Devices

Reported risk: Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters because they were identified with an incorrect expiration date, 03/2015 rather than 10/2013.

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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