Z-1866-2011

HydroHydrofilm is for use as a post-operative and primary dressing to protect against secondary infection and...

Name: Z-1866-2011 HydroHydrofilm is for use as a post-operative and primary dressing to protect against secondary infection and...
Creator: Hartmann USA, Inc
Published: 2011-02-11
License: https://open.fda.gov/license/

Hartmann USA, Inc / initiated 2011-02-11 / Terminated / root cause: labeling and UDI

FDA source

Hartmann USA, Inc began a recall of 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... on 2011-02-11. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1866-2011
Status: Terminated
Initiated: 2011-02-11
Posted: 2011-04-01
Terminated: 2011-08-12
Recalling firm: Hartmann USA, Inc
Product: 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
Product code: MGP Dressing, Wound And Burn, Occlusive
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
Root cause tag: labeling and UDI
FDA root cause: Other
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.
Quantity in commerce: 100 boxes (10 x 12.5 cm per box)
Distribution: Nationwide -- Including CA, GA, IL, MO, MS, TX, and VA.
Product codes and lots: Lot number: 000543118

Product code MGP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)