RecallRadar

FDA Device recall Z-2640-2014

Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT #…

On 2014-09-24 the FDA classified a Class II recall of Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT #… by Amerx Health Care, citing not approved labeling claims (antimicrobial and autolytic debridement).

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2640-2014
ClassificationClass II
Statusterminated
Initiated2014-07-11
Published2014-09-24
Last updated2026-09-13 11:53 UTC
CompanyAmerx Health Care
DistributionUS

Product

Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. Wound management.

Reason

Not approved labeling claims (antimicrobial and autolytic debridement)

Identifiers

code_infoLot codes: JCA0086 through JCA0106.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2640-2014%22

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