Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1
FDA Recall Z-1848-2019 · Posted None
Recalling FirmStryker GmbH
Recall StatusTerminated
Product CodeHRX
Date Initiated2019-04-30
Date Terminated2020-09-18
Product Quantity447
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.