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U.S. Department of Health and Human Services

Class 3 Device Recall Hydrofilm

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  Class 3 Device Recall Hydrofilm see related information
Date Initiated by Firm February 11, 2011
Date Posted April 01, 2011
Recall Status1 Terminated 3 on August 12, 2011
Recall Number Z-1866-2011
Recall Event ID 58136
Product Classification Dressing, wound and burn, occlusive - Product Code MGP
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
Code Information Lot number: 000543118
Recalling Firm/
Manufacturer		 Hartmann USA, Inc
481 Lakeshore Pkwy
Rock Hill SC 29730-4205
For Additional Information Contact R. Diane Awbrey
803-325-7600
Manufacturer 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
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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