Recalls / —
—#163294
Product
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
- FDA product code
- FRO — Dressing, Wound, Drug
- Device class
- Class U
- Medical specialty
- Unknown
- 510(k) numbers
- K101793
- Affected lot / code info
- Lot# 1610; 1621; 1639; 1737; 1745
Why it was recalled
Incorrect gel part number listed in a master manufacturing record
Root cause (FDA determination)
Manufacturing material removal
Action the firm took
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. .
Recalling firm
- Firm
- Integra LifeSciences Corp.
- Address
- 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344
Distribution
- Distribution pattern
- US state of RI
Timeline
- Recall initiated
- 2018-03-06
- Terminated
- 2018-07-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #163294. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.