Z-1630-2018 Class II Terminated
FDA device recall Z-1630-2018 was initiated by Integra LifeSciences Corp. on Mar 6, 2018 and is designated Class II. Reason for recall: Incorrect gel part number listed in a master manufacturing record The recall status is terminated (terminated Jul 30, 2018). Affected quantity: 766 cases.
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- Mar 6, 2018
- Termination Date
- Jul 30, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 766 cases
Product 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 for Recall
Incorrect gel part number listed in a master manufacturing record
Distribution Pattern
US state of RI
Code Information
Lot# 1610; 1621; 1639; 1737; 1745
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1630-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026