Recall Z-1630-2018 ยท FRO Dressing, Wound, Drug
Integra LifeSciences Corp.
Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lacerations and minor abrasions
| Date | Mar 6, 2018 |
| Status | Terminated |
| Reason | Incorrect gel part number listed in a master manufacturing record |
| Root cause | Manufacturing material removal |
| Action | Integra sent an Urgent Voluntary Medical Device Recall letter dated March, 6th, 2018 to distributor. The letter identified the affected product problem and actions to be taken. The letter instruct to complete and return the recall Acknowledgement form. For questions contact Customer Service at 1-800-854-2873. . |
| Quantity | 766 cases |
| Distribution | US state of RI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101793 | MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY Derma Sciences, Inc., Feb 22, 2011 |