FDA Recall
Terminated
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
Recall: Z-1630-2018
·
Initiated March 6, 2018
Recall
- Recall Number
- Z-1630-2018
- Event Number
- 79765
- Firm
- Integra LifeSciences Corp.
- FEI Number
- 3003418325
- Product Code
- FRO
- Status
- Terminated
- Root Cause
- Manufacturing material removal
- Initiated
- March 6, 2018
- Terminated
- July 30, 2018
- Address
- 311 Enterprise Dr, Plainsboro, NJ, 08536-3344
Description
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
Reason
Incorrect gel part number listed in a master manufacturing record
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. .
Distribution
US state of RI
Quantity
766 cases