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

Recall Z-1491-2013 — Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, EO; single use. Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of

U.S. FDA — Device Enforcement · United States · 2013-05-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1491-2013
Date of alert: 2013-05-23
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Stryker Instruments Div. of Stryker Corporation
Product category: device
Product type: Devices

Reported risk: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

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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