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Terminated

HEMASHIELD Knitted Double Velour Cardiovascular Fabric

FDA Recall Z-1172-2018 · Posted 2018-03-20

Recalling FirmGETINGE US SALES LLC
Recall StatusTerminated
Product CodeDXZ
Date Initiated2018-01-03
Date Terminated2018-07-03
Product Quantity1

Reason for Recall

A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length).

Firm Action

On January 3, 2018 an URGENT MEDICAL DEVICE RECALL NOTICE was issued to the (1) affected customer. A return authorization was issued with the recall letter, which is intended to be returned to the recalling firm. Questions or concerns can be directed to 1-800-528-7486

Root Cause

Labeling mix-ups

Distribution Pattern

FL

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K955349HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRICMeadox Medicals, Div. Boston Scientific Corp. · 1996-02-14

Official Source

View FDA Recall →

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

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