| Class 3 Device Recall Hydrofilm | |
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
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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
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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 |
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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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