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Terminated

BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral , and carotid arteries).

FDA Recall Z-2556-2018 · Posted None

Recalling FirmCryoLife, Inc.
Recall StatusTerminated
Product CodeMUQ
Date Initiated2018-06-04
Date Terminated2019-02-08
Product Quantity855 Total

Reason for Recall

The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly applied to the Syringe Applicator Tip pouches and Syringe Spreader Tip pouches were not included in the boxes.

Firm Action

CyroLife notified their customers on/about 06/04/2018 via Urgent - Important Product Removal letter. instructions indicated that affected pouches have been returned to CryoLife, Inc. Any questions/clarifications regarding this removal are directed to contact 800-438-8285 or by email to fieldassurance@c ryolife.com.

Root Cause

Error in labeling

Distribution Pattern

Distribution is to Japan

Official Source

View FDA Recall →

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

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