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Terminated

Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1

FDA Recall Z-1849-2019 · Posted None

Recalling FirmStryker GmbH
Recall StatusTerminated
Product CodeHRX
Date Initiated2019-04-30
Date Terminated2020-09-18
Product Quantity1600

Reason for Recall

The seal integrity of the sterile bag containing the kits may be compromised.

Firm Action

Urgent Medical Device Recall notification letters dated 4/30/19 were sent to customers.

Root Cause

Under Investigation by firm

Distribution Pattern

The products were distributed US nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K922391ENDOSCOPIC CARPAL TUNNEL INSTRUMENTSInstratek, Inc. · 1992-08-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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