Summary
The FDA issued a Class II for FORWARD Gunshot Wound Kit; Model: AFT-GSW; by INTEGRATED MEDCRAFT LLC. Reason: Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causin.
Details
Source
Device Recall
External ID
Z-0147-2027
Action Date
2026-10-21
Status
Ongoing
Category
device
Product Description
FORWARD Gunshot Wound Kit; Model: AFT-GSW;
Lot/Code Info: Model: ATF-GSW; UDI-DI: 00850056748063; Lot Numbers: IMC-00000024, IMC-00000034, IMC-00000053, IMC-00000056, IMC-00000076, IMC-00000081, IMC-00000082, IMC-00000083, IMC-00000084, IMC-00000085, IMC-00000094, IMC-00000148, IMC-00000149, IMC-00000152, IMC-00000153, IMC-00000154, IMC-00000173, IMC-00000174, IMC-00000179, IMC-00000186, IMC-00000187;
Quantity Affected: 1033
Reason for Recall
Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad to degrade over time. The degradation may cause remnants of the nonwoven pad material to dislodge on the wound or in close proximity to the wound.
Distribution
US Nationwide distribution in the states of GA, VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-25
Company
East Hampton, CT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 150 device recalls issued in the same week, part of 446 device-related FDA actions this month.
INTEGRATED MEDCRAFT LLC has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (INTEGRATED MEDCRAFT LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does INTEGRATED MEDCRAFT LLC have FDA actions?
INTEGRATED MEDCRAFT LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0147-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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