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Terminated

EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm: L: 50 mm straight Maquet Cardiovascular LLS, 45 Barbour Pond Drive, Wayne, NJ 07470

FDA Recall Z-0866-2010 · Posted 2010-02-26

Recalling FirmMaquet Cardiovascular, LLC
Recall StatusTerminated
Product CodeDSY
Date Initiated2010-01-20
Date Terminated2010-07-06
Product Quantity18 units

Reason for Recall

Labeling mix up: Shelf Carton label for Exxcel Soft Thin Wall Vascular Grafts, lot # 12633379 were mislabeled as Exxcel Soft Standard Wall Grafts. Bleeding could occur if wrong product is used.

Firm Action

Recall letters were sent to all US customers on January 20, 2010 by certified mail. Letters for foreign consignees were to be sent as soon as translation was completed. Customer are directed to call the company at 973-709-7515 for more information.

Root Cause

Labeling mix-ups

Distribution Pattern

Product was distributed to hospitals in TX, TN, CT, AR, AZ as well as to Austria and France.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052964EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVENBoston Scientific Corp · 2006-01-06

Official Source

View FDA Recall →

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

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