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Terminated

HydroHydrofilm is for use as a post-operative and primary dressing to protect against secondary infection and to cover non-exudating wounds and for use as a secondary dressing for fixation of catheters or cannulae.film, 10cm x 12.5 cm, Paul Hartmann AG, 89522 Heidenhiem, Germany

FDA Recall Z-1866-2011 · Posted 2011-04-01

Recalling FirmHartmann USA, Inc
Recall StatusTerminated
Product CodeMGP
Date Initiated2011-02-11
Date Terminated2011-08-12
Product Quantity100 boxes (10 x 12.5 cm per box)

Reason for Recall

Misbranded; the expiry date on the primary packing incorrectly indicates 2010-10, instead of 2015-10. Consignees were notified by letter on/about 02/11/2011. They were advised to examine their inventory and not to use any of the affected product and to return it to Paul Hartmann. A response form was included to be completed and returned to Paul Hartmann. They were further instructed to pass the no

Firm Action

Hartmann USA, Inc. sent letter to the Consignees on 2/11/11. They were advised to examine their inventory and not to use any of the affected product and to return it to Hartmann USA, Inc. A response form was included to be completed and returned to Hartmann USA, Inc. They were further instructed to pass the notice on to their consignees if distributed. For questions, call (803) 325-7600.

Root Cause

Other

Distribution Pattern

Nationwide -- Including CA, GA, IL, MO, MS, TX, and VA.

Official Source

View FDA Recall →

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

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