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Terminated

PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, M002000193821, M002000193931, M002000193841, M002000193861, M002000193881.

FDA Recall Z-0931-05 · Posted 2005-06-25

Recalling FirmBoston Scientific Scimed
Recall StatusTerminated
Product CodeDXZ
Date Initiated2005-04-19
Date Terminated2006-10-03
Product Quantity290 packs containing 5 pieces of Felt.

Reason for Recall

Units of these lots may have areas of lower density resulting in lower tensile and suture retention strength.

Firm Action

Recall letters letters were sent to all customers on 4/19/2005 with instructions to discontinue using the identified felt products.

Root Cause

Other

Distribution Pattern

The product was distributed to hospitals nationwide.

Official Source

View FDA Recall →

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

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